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

NCT05653271 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-08-11

No results posted yet for this 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

Interventions

DRUG

Cyclophosphamide

Lymphodepleting agent

DRUG

Fludarabine

Lymphodepleting agent

DRUG

ACE1831

Allogeneic gamma delta T (gdT) cell therapy

DRUG

Obinutuzumab

Anti-CD20 monoclonal antibody

Sponsors & Collaborators

  • Acepodia Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-21
Primary Completion
2025-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05653271 on ClinicalTrials.gov