Clinical Trials List
Protocol NumberDSP-5336-101
NCT Number(ClinicalTrials.gov Identfier)NCT04988555
Active
2023-06-01 - 2027-10-31
Phase I/II
Recruiting3
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients With Acute Leukemia and Other Selected Hematologic Malignancies, With and Without Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林明恩 無
- YAO CHI-YUAN 無
- MING YAO 無
- CHENG-HONG TSAI 無
- 田豐銘 無
- HSIN-AN HOU 無
- Huai-Hsuan Huang 無
- Chien-Chin Lin 無
- 袁章祖 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Leukemia, Myeloid, Acute 、Leukemia, Lymphocytic, Acute
Objectives
A complete list of objectives and targets (including exploratory objectives and targets) should be included in the full experimental plan.
Phase 1
Primary Objectives
• Evaluate the safety and tolerability of DSP-5336 monotherapy in patients with relapsed or refractory AML, ALL, or acute leukemia of unknown lineage, and also evaluate its safety and tolerability in patients with high-risk relapsed or refractory MDS or relapsed/refractory MM (in the United States).
• Determine the Phase 2 Recommended Dosage (RP2D) of DSP-5336 based on the lowest or maximum tolerated dose (MTD) that produces the greatest biological and clinical effect, whichever is lower.
• Confirm the safety, tolerability, and RP2D of DSP-5336 in combination with venetoclax/azacitidine in adult patients with relapsed or refractory AML.
• Confirm the safety, tolerability, and RP2D of DSP-5336 in combination with gilteritinib in adult patients with relapsed or refractory AML.
Secondary Objectives
• Describe DSP-5336 The pharmacokinetic properties of DSP-5336, including its pharmacokinetic properties when used in combination with selected azole drugs, namely: posaconazole, voriconazole, or fluconazole.
• Evaluate the effect of food (high-fat diet) on the pharmacokinetics/exposure of DSP-5336.
• Evaluate the effect of DSP-5336 on the pharmacokinetics/exposure of midazolam and caffeine.
• Evaluate the pharmacokinetic properties of DSP-5336 in combination with venetoclax and azacitidine.
• Evaluate the pharmacokinetic properties of DSP-5336 in combination with gilteritinib.
• Evaluate the pharmacokinetic properties of venetoclax in combination with DSP-5336.
• Evaluate the pharmacokinetic properties of gilteritinib in combination with DSP-5336.
• Evaluate DSP-5336. Preliminary clinical activity of DSP-5336 as monotherapy in adult patients with acute myeloid leukemia, acute lymphoblastic leukemia, or acute leukemia of unknown lineage; preliminary clinical activity also evaluated in patients with high-risk relapsed or refractory MDS or relapsed/refractory MM (in the United States).
• Evaluation of the preliminary clinical activity of DSP-5336 in combination with venetoclax/azacitidine
• Evaluation of the preliminary clinical activity of DSP-5336 in combination with gilteritinib
• Determination of the cardiac safety of DSP-5336 as monotherapy through 12-lead safety and intensive ECG monitoring, and through 12-lead safety ECG monitoring in the presence of azole drugs.
Phase 2
Primary Objective
• Evaluation of DSP-5336 monotherapy in patients with relapsed/refractory acute leukemia with MLLr, or relapsed/refractory AML with NPM1m Clinical Activity in Patients
Secondary Objectives
• Evaluate the clinical activity of DSP-5336 monotherapy in patients with relapsed/refractory acute leukemia with MLLr, or patients with relapsed/refractory AML with NPM1m.
• Further evaluate the safety and tolerability of DSP-5336.
Test Drug
錠劑
Active Ingredient
DSP-5336
Dosage Form
110
Dosage
NA
Endpoints
Phase 1
Safety:
• Dose-limiting toxicities (DLTs) assessed according to the National Cancer Institute Common Adverse Event Evaluation Criteria (NCI CTCAE) version 5.0
• Treatment-related adverse events (TEAEs) and serious adverse events (SAEs)
• Changes in vital signs, clinical laboratory values (hematology, clinical chemistry, urinalysis), electrocardiogram (ECG) parameters, and echocardiographic (ECHO) parameters
Tolerability:
• Dose interruption, dose reduction, and/or dose discontinuation
Bioefficacy:
• Please refer to the corresponding secondary endpoints for PK and clinical activity
• Please refer to the corresponding exploratory endpoints for biomarkers (gene expression levels)
For acute leukemia:
Response achieved according to the CRh criteria defined by ELN 2017 and FDA guidelines
• Complete remission (CR); Complete remission with partial hematologic recovery (CRh); Complete remission with incomplete hematologic recovery (CRi); Partial remission (PR); Morphologically aleukemic state (MLFS); CR + CRh; Composite Complete Remission (CRc [CR or CRh or CRi]): Objective Response Rate (ORR [= CR or CRi or MLFS]); Time to CR/CRh; Time to ORR; Duration of CR/CRh; Duration of ORR; Transfusion Independence (TI); Overall Survival (OS); Event-Free Survival (EFS) For MDS (in the US): Initial activity will be assessed according to the 2023 IWG criteria and the proportion of patients achieving a response subtype and/or hematologic improvement will be reported (e.g., complete remission, complete remission but limited count recovery). Phase 2 • CR + CRh as defined by FDA guidance
Safety:
• Dose-limiting toxicities (DLTs) assessed according to the National Cancer Institute Common Adverse Event Evaluation Criteria (NCI CTCAE) version 5.0
• Treatment-related adverse events (TEAEs) and serious adverse events (SAEs)
• Changes in vital signs, clinical laboratory values (hematology, clinical chemistry, urinalysis), electrocardiogram (ECG) parameters, and echocardiographic (ECHO) parameters
Tolerability:
• Dose interruption, dose reduction, and/or dose discontinuation
Bioefficacy:
• Please refer to the corresponding secondary endpoints for PK and clinical activity
• Please refer to the corresponding exploratory endpoints for biomarkers (gene expression levels)
For acute leukemia:
Response achieved according to the CRh criteria defined by ELN 2017 and FDA guidelines
• Complete remission (CR); Complete remission with partial hematologic recovery (CRh); Complete remission with incomplete hematologic recovery (CRi); Partial remission (PR); Morphologically aleukemic state (MLFS); CR + CRh; Composite Complete Remission (CRc [CR or CRh or CRi]): Objective Response Rate (ORR [= CR or CRi or MLFS]); Time to CR/CRh; Time to ORR; Duration of CR/CRh; Duration of ORR; Transfusion Independence (TI); Overall Survival (OS); Event-Free Survival (EFS) For MDS (in the US): Initial activity will be assessed according to the 2023 IWG criteria and the proportion of patients achieving a response subtype and/or hematologic improvement will be reported (e.g., complete remission, complete remission but limited count recovery). Phase 2 • CR + CRh as defined by FDA guidance
Inclution Criteria
Inclusion Criteria:
Patients in the Phase 1 dose-escalation portion must have a diagnosis of relapsed or refractory AML, ALL or acute leukemia of ambiguous lineage according to World Health Organization (WHO) 2022 classification, or, in the US only, a diagnosis of MDS or MM as determined by pathology review at the treating institution, and whose disease has progressed after available standard therapies known to be active for their AML, ALL, or acute leukemia of ambiguous lineage or, in the US, for MM or MDS.
For patients with MDS (US only):
Patients with MDS must have IPSS-R risk categorization of "high" or "very high" at initial diagnosis or at study entry and have bone marrow blasts ≥ 5% (which is the definition of high-risk MDS in this study)
Patients with MDS must have relapsed or refractory disease and have exhausted available standard therapies including at least 2 cycles of treatment with HMA
For patients with MM (US only):
Have a confirmed diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) 2016 classification (Kumar, 2016) and whose disease has progressed after treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb); patients must not be candidates for available therapies with established clinical benefit
Have measurable disease as defined in the protocol
Meet the laboratory parameters set in the protocol
For patients with relapsed/refractory AML in the venetoclax and azacitidine combination cohort (in countries and sites where permitted):
Have MLLr or NPM1m.
For patients with relapsed/refractory AML in the gilteritinib combination cohort (in countries and sites where permitted):
Have MLLr or NPM1m AND any of the following FLT3 mutations: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836.
Patients in the Phase 2 dose expansion portion of the study must have a confirmed diagnosis of relapsed AML or ALL as determined by pathology review at the treating institution, and who have ≥5% blasts by morphologic assessment in the bone marrow and failed available standard therapies known to be active for their AML (Arm G and H) or ALL (Arm I). If the primary disease is a transformation from MDS or other hematologic malignancies, patients need to receive available standard therapies for acute leukemia before enrolling this trial. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option. Patients with extramedullary disease or peripheral blasts as the only manifestation of relapse are not eligible.
Patients must not have had prior exposure to a menin inhibitor
Patients for Arms G and H are limited to a total of 3 prior lines of therapy, with induction chemotherapy, consolidation chemotherapy, and stem cell transplantation with or without subsequent maintenance treatment considered to be 1 line.
Have a documented KMT2A (MLL)-fusion for Arm G and I or NPM1 mutation for Arm H assessed at relapse or immediately prior to the determination of refractory status. For Arms G and I, KMT2A genetic alterations other than fusions (eg, KMT2A-PTD, amplification, point mutation) are not permitted.
Be > 18 years of age. For countries and sites where approved, for DSP-5336 monotherapy, acute leukemia patients ≥12 years of age who weigh ≥40 kg may be enrolled.
ECOG < 2; For Phase 2 only, patients must have an ECOG performance status 0 or 1.
For monotherapy, WBC below 30,000/μ. For the combination arms, WBC count must be below 25,000/uL at enrollment and prior to starting treatment. (Hydroxyurea and steroids for cytoreduction purposes are allowed prior to enrollment and during study treatment)
Clearance of creatinine (CLcr) level ≥ 50 ml/min, assessed by the Cockcroft-Gault formula
Total bilirubin ≤1.5 the upper limit of normal (ULN) (or ≤2.0 ULN for patients with known Gilbert's syndrome)
Aspartate aminotransferase (AST) ≤3.0 times ULN
Alanine aminotransferase (ALT) ≤3.0 times ULN
Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia or neuropathy.
Be willing to attend study visits as required by the protocol
Have an estimated life expectancy ≥3 months, based on the investigator's assessment
Females of childbearing potential must have a negative serum pregnancy test.
Must agree to use a highly effective contraception method or 2 acceptable methods of birth control (each partner must use one method) or use prevention of pregnancy measures (ie, agreement to refrain completely from heterosexual intercourse) during the study and for 6 months (for females and males alike) after the last dose of study drug, if male or female patient is of child-producing potential
For sites in Japan only: Implantable hormonal contraceptives, a diaphragm with spermicide, cervical cap with spermicide and contraceptive sponge (spermicide is already in the contraceptive sponge) included in the barrier contraceptive method are not approved and cannot be used in Japan.
Have AML/ALL/MDS/MM bone marrow material suitable for genomic analysis of AML,ALL, MDS, or MM genetic alterations. Note: If a bone marrow material is insufficient, an alternative suitable tissue (ex: peripheral blood) must be provided.
Patients in the Phase 1 dose-escalation portion must have a diagnosis of relapsed or refractory AML, ALL or acute leukemia of ambiguous lineage according to World Health Organization (WHO) 2022 classification, or, in the US only, a diagnosis of MDS or MM as determined by pathology review at the treating institution, and whose disease has progressed after available standard therapies known to be active for their AML, ALL, or acute leukemia of ambiguous lineage or, in the US, for MM or MDS.
For patients with MDS (US only):
Patients with MDS must have IPSS-R risk categorization of "high" or "very high" at initial diagnosis or at study entry and have bone marrow blasts ≥ 5% (which is the definition of high-risk MDS in this study)
Patients with MDS must have relapsed or refractory disease and have exhausted available standard therapies including at least 2 cycles of treatment with HMA
For patients with MM (US only):
Have a confirmed diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) 2016 classification (Kumar, 2016) and whose disease has progressed after treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb); patients must not be candidates for available therapies with established clinical benefit
Have measurable disease as defined in the protocol
Meet the laboratory parameters set in the protocol
For patients with relapsed/refractory AML in the venetoclax and azacitidine combination cohort (in countries and sites where permitted):
Have MLLr or NPM1m.
For patients with relapsed/refractory AML in the gilteritinib combination cohort (in countries and sites where permitted):
Have MLLr or NPM1m AND any of the following FLT3 mutations: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836.
Patients in the Phase 2 dose expansion portion of the study must have a confirmed diagnosis of relapsed AML or ALL as determined by pathology review at the treating institution, and who have ≥5% blasts by morphologic assessment in the bone marrow and failed available standard therapies known to be active for their AML (Arm G and H) or ALL (Arm I). If the primary disease is a transformation from MDS or other hematologic malignancies, patients need to receive available standard therapies for acute leukemia before enrolling this trial. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option. Patients with extramedullary disease or peripheral blasts as the only manifestation of relapse are not eligible.
Patients must not have had prior exposure to a menin inhibitor
Patients for Arms G and H are limited to a total of 3 prior lines of therapy, with induction chemotherapy, consolidation chemotherapy, and stem cell transplantation with or without subsequent maintenance treatment considered to be 1 line.
Have a documented KMT2A (MLL)-fusion for Arm G and I or NPM1 mutation for Arm H assessed at relapse or immediately prior to the determination of refractory status. For Arms G and I, KMT2A genetic alterations other than fusions (eg, KMT2A-PTD, amplification, point mutation) are not permitted.
Be > 18 years of age. For countries and sites where approved, for DSP-5336 monotherapy, acute leukemia patients ≥12 years of age who weigh ≥40 kg may be enrolled.
ECOG < 2; For Phase 2 only, patients must have an ECOG performance status 0 or 1.
For monotherapy, WBC below 30,000/μ. For the combination arms, WBC count must be below 25,000/uL at enrollment and prior to starting treatment. (Hydroxyurea and steroids for cytoreduction purposes are allowed prior to enrollment and during study treatment)
Clearance of creatinine (CLcr) level ≥ 50 ml/min, assessed by the Cockcroft-Gault formula
Total bilirubin ≤1.5 the upper limit of normal (ULN) (or ≤2.0 ULN for patients with known Gilbert's syndrome)
Aspartate aminotransferase (AST) ≤3.0 times ULN
Alanine aminotransferase (ALT) ≤3.0 times ULN
Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia or neuropathy.
Be willing to attend study visits as required by the protocol
Have an estimated life expectancy ≥3 months, based on the investigator's assessment
Females of childbearing potential must have a negative serum pregnancy test.
Must agree to use a highly effective contraception method or 2 acceptable methods of birth control (each partner must use one method) or use prevention of pregnancy measures (ie, agreement to refrain completely from heterosexual intercourse) during the study and for 6 months (for females and males alike) after the last dose of study drug, if male or female patient is of child-producing potential
For sites in Japan only: Implantable hormonal contraceptives, a diaphragm with spermicide, cervical cap with spermicide and contraceptive sponge (spermicide is already in the contraceptive sponge) included in the barrier contraceptive method are not approved and cannot be used in Japan.
Have AML/ALL/MDS/MM bone marrow material suitable for genomic analysis of AML,ALL, MDS, or MM genetic alterations. Note: If a bone marrow material is insufficient, an alternative suitable tissue (ex: peripheral blood) must be provided.
Exclusion Criteria
Exclusion Criteria:
Has a left ventricular ejection fraction (LVEF) <50%, as determined by ECHO
Histological diagnosis of acute promyelocytic leukemia
Received systemic calcineurin inhibitors within 2 weeks prior to the first dose of DSP 5336
Have abnormal ECGs at screening that are clinically significant, such as (QTc >480 msec, with QTc corrected according to Fridericia's formula (QTcF). Note: In case of bundle branch block, QT interval correction can be performed.
Has an active anduncontrolled, bacterial, viral, or fungal infection requiring parenteral therapy. Note: Patients must be afebrile with negative blood cultures at least 72 hours prior to Cycle 1 Day 1.
Receives concurrent sensitive substrates with a narrow safety window or strong inhibitors or inducers of CYP3A4/5, including specifically: ketoconazole, isavuconazole and itraconazole. Other antifungals that are used as standard of care to prevent or treat infections are permitted. If a patient is on one of the excluded azole class antifungals, he/she can be taken off or switched to a permitted azole 7 or more days prior to first dose, then the patient could be allowed on study (Arm B) with approval of the medical monitor.
Received immunotherapy, including tumor vaccines and checkpoint inhibitors, within 42 days prior to the first dose of DSP-5336
Had major surgery within 28 days prior to the first dose of DSP-5336
Has active central nervous system leukemia. Patients with a history of any CNS leukemia involvement are excluded from Phase 2 Arms G and H.
Underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336. Patients who have received >1 prior HSCT are excluded from Phase 2 Arms G and H.
Received a donor lymphocyte infusion within 28 days prior to the first dose of DSP-5336, or receiving immunosuppressive therapy post-HSCT at the time of screening, or with clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD
Received antineoplastic agents (except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells) or other investigational treatment within 14 days or 5 half-lives, whichever is shortest, prior to the first dose of DSP-5336
In the opinion of the treating investigator, have any concurrent conditions that could pose an undue medical hazard or interfere with interpretation of study results
Have a known detectable viral load for human immunodeficiency virus or hepatitis C, or evidence of hepatitis B surface antigen, all being indicative of active infection.
For sites in Japan, Taiwan, and Korea only: Hepatitis B core (HBc) antibody or hepatitis B surface (HBs) antibody test should be performed if HBsAg is negative. If HBc antibody or HBs antibody test is positive, HBV DNA quantification test should be performed to confirm that HBV DNA is negative.
Have severe dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication
Have cognitive, psychologic, or psychosocial impediment that would impair the ability of the patient o receive therapy according to the protocol, or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures
Are pregnant or breastfeeding or planning to become pregnant. Note: Patients who are breastfeeding may be enrolled if they interrupt breastfeeding prior to the first dose of any study drugs and do not feed the baby with breast milk expressed after receiving the first dose of any study drugs. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug
Have any history or complication of interstitial lung disease (for sites in Japan in Phase 1 dose escalation only).
For clinical sites in the EU, have a history of Grade ≥ 2 drug-induced interstitial lung disease or Grade ≥ 2 non-infectious pneumonitis within 6 months of starting study treatment.
Have a history of Torsades de Pointes
Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP-5336
Have plasma cell leukemia (>2.0 x 109 /L plasma cells in blood by standard differential) (for patients with MM only)
For patients intending to enroll into the combination cohort with gilteritinib: Patients must be gilteritinib-naïve or sensitive and have not received a FLT3 inhibitor in the relapsed refractory setting (prior FLT3 inhibitor in front line therapy is allowed)
Have a known intolerance of hypersensitivity reaction to components of the investigational medicinal product
Patients with LDH >500 U/L (>8.3 µkat/L) are excluded from Phase 2 Arms G and H
Has a left ventricular ejection fraction (LVEF) <50%, as determined by ECHO
Histological diagnosis of acute promyelocytic leukemia
Received systemic calcineurin inhibitors within 2 weeks prior to the first dose of DSP 5336
Have abnormal ECGs at screening that are clinically significant, such as (QTc >480 msec, with QTc corrected according to Fridericia's formula (QTcF). Note: In case of bundle branch block, QT interval correction can be performed.
Has an active anduncontrolled, bacterial, viral, or fungal infection requiring parenteral therapy. Note: Patients must be afebrile with negative blood cultures at least 72 hours prior to Cycle 1 Day 1.
Receives concurrent sensitive substrates with a narrow safety window or strong inhibitors or inducers of CYP3A4/5, including specifically: ketoconazole, isavuconazole and itraconazole. Other antifungals that are used as standard of care to prevent or treat infections are permitted. If a patient is on one of the excluded azole class antifungals, he/she can be taken off or switched to a permitted azole 7 or more days prior to first dose, then the patient could be allowed on study (Arm B) with approval of the medical monitor.
Received immunotherapy, including tumor vaccines and checkpoint inhibitors, within 42 days prior to the first dose of DSP-5336
Had major surgery within 28 days prior to the first dose of DSP-5336
Has active central nervous system leukemia. Patients with a history of any CNS leukemia involvement are excluded from Phase 2 Arms G and H.
Underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336. Patients who have received >1 prior HSCT are excluded from Phase 2 Arms G and H.
Received a donor lymphocyte infusion within 28 days prior to the first dose of DSP-5336, or receiving immunosuppressive therapy post-HSCT at the time of screening, or with clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD
Received antineoplastic agents (except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells) or other investigational treatment within 14 days or 5 half-lives, whichever is shortest, prior to the first dose of DSP-5336
In the opinion of the treating investigator, have any concurrent conditions that could pose an undue medical hazard or interfere with interpretation of study results
Have a known detectable viral load for human immunodeficiency virus or hepatitis C, or evidence of hepatitis B surface antigen, all being indicative of active infection.
For sites in Japan, Taiwan, and Korea only: Hepatitis B core (HBc) antibody or hepatitis B surface (HBs) antibody test should be performed if HBsAg is negative. If HBc antibody or HBs antibody test is positive, HBV DNA quantification test should be performed to confirm that HBV DNA is negative.
Have severe dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication
Have cognitive, psychologic, or psychosocial impediment that would impair the ability of the patient o receive therapy according to the protocol, or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures
Are pregnant or breastfeeding or planning to become pregnant. Note: Patients who are breastfeeding may be enrolled if they interrupt breastfeeding prior to the first dose of any study drugs and do not feed the baby with breast milk expressed after receiving the first dose of any study drugs. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug
Have any history or complication of interstitial lung disease (for sites in Japan in Phase 1 dose escalation only).
For clinical sites in the EU, have a history of Grade ≥ 2 drug-induced interstitial lung disease or Grade ≥ 2 non-infectious pneumonitis within 6 months of starting study treatment.
Have a history of Torsades de Pointes
Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP-5336
Have plasma cell leukemia (>2.0 x 109 /L plasma cells in blood by standard differential) (for patients with MM only)
For patients intending to enroll into the combination cohort with gilteritinib: Patients must be gilteritinib-naïve or sensitive and have not received a FLT3 inhibitor in the relapsed refractory setting (prior FLT3 inhibitor in front line therapy is allowed)
Have a known intolerance of hypersensitivity reaction to components of the investigational medicinal product
Patients with LDH >500 U/L (>8.3 µkat/L) are excluded from Phase 2 Arms G and H
The Estimated Number of Participants
-
Taiwan
NA participants
-
Global
NA participants
