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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 Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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