Clinical Trials List
2023-04-01 - 2026-12-31
Phase I
Not yet recruiting4
Recruiting4
A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic Anti-CD20 Antibody-Conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 林建鴻 主任 Division of Hematology & Oncology
- 張明志 資深主治醫師 Division of Hematology & Oncology
- 蘇迺文 主治醫師 Division of Hematology & Oncology
- 江翊豪 資深主治醫師 Division of Hematology & Oncology
- 陳功深 主治醫師 Division of Hematology & Oncology
- 張義芳 資深主治醫師 Division of Hematology & Oncology
- 林炯森 資深主治醫師 Division of Hematology & Oncology
- 陳洛合 主治醫師 Division of Hematology & Oncology
- 張育誠 資深主治醫師 Division of Hematology & Oncology
- 宋孟達 主治醫師 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Chung Kao Division of Hematology & Oncology
- 張鴻 醫師 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
2. To determine the recommended dose for the Phase II clinical trial of ACE1831.
Secondary Objectives:
1. To evaluate the pharmacokinetics of ACE1831.
2. To evaluate the immunogenicity of ACE1831.
3. To evaluate the efficacy of ACE1831 as monotherapy or in combination with obinutuzumab (GAZYVA) in patients with relapsed/refractory B-cell lymphoma.
Exploratory Objective: To evaluate the pharmacodynamics of ACE1831.
Inclution Criteria
CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines
At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or subjects with ECOG scores of 2 with a serum albumin of >3.5
Adequate hematologic and renal, hepatic, and cardiac function
Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air
Exclusion Criteria
Prior treatment with a genetically modified cell therapy product targeting CD20
Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation
History of central nervous system (CNS) lymphoma or primary CNS lymphoma
History or presence of clinically relevant CNS disorder (e.g. epilepsy)
Clinically significant active infection
Currently active, clinically significant cardiovascular disease
Human Immunodeficiency virus (HIV) infection (however, subjects on anti-retroviral therapy for at least 4 weeks and with HIV viral loads of <400 copies/mL are eligible), active hepatitis B infection, or hepatitis C infection
History of other malignancies with the exception of certain treated malignancies with no evidence of disease
Primary immunodeficiency disorder
Pregnant or lactating female
Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment, comply with study requirements, or understanding of the informed consent
The Estimated Number of Participants
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Taiwan
12 participants
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Global
42 participants
