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OncoMatch/Clinical Trials/NCT05653271

ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies

Is NCT05653271 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cyclophosphamide and Fludarabine for b-cell lymphoma.

Phase 1RecruitingAcepodia Biotech, Inc.NCT05653271Data as of May 2026

Treatment: Cyclophosphamide · Fludarabine · ACE1831 · Obinutuzumab — 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Hodgkin Lymphoma

Diffuse Large B-Cell Lymphoma

Biomarker criteria

Required: MS4A1 overexpression (CD20-positive)

CD20-positive B-cell NHL

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Cannot have received: genetically modified cell therapy targeting CD20

Prior treatment with a genetically modified cell therapy product targeting CD20

Cannot have received: autologous stem cell transplant

Exception: allowed if >6 weeks since informed consent

Autologous stem cell transplant within 6 weeks of informed consent

Cannot have received: allogeneic stem cell transplant

history of allogeneic stem cell transplantation

Lab requirements

Blood counts

adequate hematologic function

Kidney function

adequate renal function

Liver function

adequate hepatic function

Cardiac function

adequate cardiac function; oxygen saturation via pulse oxygenation ≥ 92% at rest on room air

Adequate hematologic and renal, hepatic, and cardiac function; Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • AdventHealth Orlando · Orlando, Florida
  • Emory University · Atlanta, Georgia
  • Indiana University Simon Comprehensive Cancer Center · Indianapolis, Indiana
  • Norton Cancer Institute · Louisville, Kentucky
  • The University of Texas MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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