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

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05653271
Protocol IDs
ACE1831-001 (primary)
NCI-2023-03335
Study Sponsor
Acepodia Biotech, Inc.

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.

Eligibility

  1. CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines
  2. At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. Adequate hematologic and renal, hepatic, and cardiac function
  5. Oxygen saturation via pulse oxygenation = 92% at rest on room air

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.