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ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
NCT05653271 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG ACE1831
Study Locations (13)
Other
- Queen Mary Hospital — Hong Kong
- Kaohsiung Chang-Gung Memorial Hospital — Kaohsiung City
- Ministry of Health and Welfare Shuang-Ho Hospital — New Taipei City
- Tamsui MacKay Memorial Hospital — New Taipei City
- Taichung Veterans General Hospital — Taichung
- National Cheng Kung University Hospital — Tainan
- National Taiwan University Hospital — Taipei
- Linkou Chang-Gung Memorial Hospital — Taoyuan
Florida
- AdventHealth Orlando — Orlando
Georgia
- Emory University — Atlanta
Indiana
- Indiana University Simon Comprehensive Cancer Center — Indianapolis
Kentucky
- Norton Cancer Institute — Louisville
Texas
- The University of Texas MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-01-21 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05653271
The ClinicalTrials.gov registry entry for NCT05653271 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acepodia Biotech, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Follicular Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which Obinutuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05653271 reports 13 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05653271 about?
NCT05653271 is a clinical study titled "ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies". 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 an...
What is the current status of trial NCT05653271?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2023-01-21. Estimated completion is 2027-09.
What conditions does trial NCT05653271 study?
This clinical trial studies the following conditions: Follicular Lymphoma, Marginal Zone Lymphoma, Non Hodgkin Lymphoma, Burkitt Lymphoma, High-grade B-cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05653271?
The interventions under investigation include: Obinutuzumab (DRUG), Cyclophosphamide (DRUG), Fludarabine (DRUG), ACE1831 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05653271?
This trial is sponsored by Acepodia Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05653271 being conducted?
This trial has 13 study locations across Florida, Georgia, Indiana, Kentucky, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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