Actively Recruiting
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
Led by Acepodia Biotech, Inc. · Updated on 2025-08-11
42
Participants Needed
13
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of CD20-expressing B-cell malignancies. The ACE1831-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and efficacy of ACE1831 in patients with CD20-expressing Non-Hodgkin lymphoma.
CONDITIONS
Official Title
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with CD20-positive B-cell Non-Hodgkin lymphoma that is persistent or progressive after at least 2 prior systemic therapies
- At least 1 measurable lesion per revised International Working Group Response Criteria for Malignant Lymphoma
- 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 at least 92% 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 history of allogeneic stem cell transplantation
- History of central nervous system lymphoma or primary CNS lymphoma
- History or presence of clinically relevant central nervous system disorders such as epilepsy
- Clinically significant active infections
- Active, clinically 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 disorders
- Pregnant or breastfeeding females
- Any condition that impairs ability to receive study treatment, comply with requirements, or understand informed consent as judged by investigators or medical monitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here