ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies (NCT05653271) | Clinical Trial Compass
Active — Not RecruitingPhase 1
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
United States, Hong Kong, Taiwan42 participantsStarted 2023-01-21
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion 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
Key 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 sociolog…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since ACE1831 is a Phase 1 trial focused on finding the maximum tolerated dose and measuring safety events like dose-limiting toxicities, what does that mean for what's currently known — and not yet known — about whether it might actually shrink my specific type of lymphoma?
2My diagnosis is one of several B-cell malignancies this trial includes, such as DLBCL or follicular lymphoma — does my particular subtype make me a better or less suitable candidate compared to others in the study, and how might that affect my experience?
3The trial is actively enrolling but no longer recruiting new participants — does that mean enrollment is closed, and if so, are there other similar early-phase CD20-targeting trials you'd recommend I look into instead?
4Because this is a Phase 1 study tracking things like ECG changes, lab results, and vital signs at multiple time points, how frequent would my monitoring visits need to be, and would that level of commitment be manageable alongside my current health situation?
5Before considering a Phase 1 trial like this, should I first explore whether any approved standard treatments or later-phase studies might be a better fit for my stage and condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Timeframe: 2 years
2
Change from baseline in ECOG status
Timeframe: 1 year
3
Change from baseline in physical examination results
Timeframe: 1 year
4
Change from baseline clinical laboratory tests results
Timeframe: 1 year
5
Change from baseline in urinalysis results
Timeframe: 1 year
6
Change from baseline in vital signs results
Timeframe: 1 year
7
Change from baseline in electrocardiogram (ECG) results