Actively Recruiting
A Phase 1 Study of ACE1831, an Allogeneic Anti-CD20 Gamma Delta T-cell Therapy, in Adults With Relapsed/Refractory CD20-expressing B-cell Malignancies
Led by Acepodia Biotech, Inc. · Updated on 2025-08-11
42
Participants Needed
13
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ACE1831, a type of off-the-shelf allogeneic gamma delta T-cell therapy made from healthy donors, in adults with CD20-expressing B-cell malignancies such as Non-Hodgkin lymphoma. This Phase 1, open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of ACE1831 in patients with relapsed or refractory disease after at least two prior treatments. Participants receive a lymphodepleting regimen with drugs cyclophosphamide and fludarabine, followed by escalating doses of ACE1831 either alone or combined with obinutuzumab, an anti-CD20 antibody. The study includes two treatment groups: one with ACE1831 monotherapy and another with ACE1831 plus obinutuzumab. Dose escalation helps determine the maximum tolerated dose and explore the therapy's effects. During the trial, participants will be monitored for adverse events, laboratory changes, vital signs, ECG results, and physical examinations over various timeframes up to two years. Researchers will also measure response rates, persistence of ACE1831 therapy, and antibody development. The total study duration for each participant includes safety follow-up and evaluation of clinical outcomes related to the treatment.
CONDITIONS
Brief Title
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with CD20-positive B-cell Non-Hodgkin lymphoma persistent or progressing after at least 2 prior systemic therapies
- At least one measurable lymphoma lesion
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, or 2 with serum albumin >3.5
- Adequate hematologic, renal, hepatic, and cardiac function
- Oxygen saturation of 92% or higher at rest on room air
You will not qualify if you...
- Prior treatment with genetically modified cell therapy targeting CD20
- Autologous stem cell transplant within 6 weeks before consent or any history of allogeneic stem cell transplantation
- History of central nervous system lymphoma or primary CNS lymphoma
- History or presence of significant CNS disorders such as epilepsy
- Clinically significant active infection
- Active, significant cardiovascular disease
- HIV infection (unless on anti-retroviral therapy for at least 4 weeks with viral load <400 copies/mL), active hepatitis B or C infection
- History of other malignancies except certain treated malignancies with no evidence of disease
- Primary immunodeficiency disorder
- Pregnant or breastfeeding women
- Any medical, psychological, familial, or social condition that could impair ability to receive treatment or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants receive a lymphodepleting drug regimen followed by escalating doses of ACE1831, either alone or in combination with obinutuzumab.
Multiple visits during dosing period
Duration - Up to 2 years
Participants are monitored for safety, clinical response, and persistence of ACE1831 after treatment completion.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 13 locations
1
AdventHealth Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Terminated
4
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
5
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
7
Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
8
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City, Taiwan
Actively Recruiting
9
Tamsui MacKay Memorial Hospital
New Taipei City, Taiwan
Actively Recruiting
10
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
11
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
12
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
13
Linkou Chang-Gung Memorial Hospital
Taoyuan City, Taiwan
Actively Recruiting
Research Team
S
Stephanie Chien
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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