RecruitingPhase 1NCT05653271

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

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic Anti-CD20 Antibody-Conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies


Sponsor

Acepodia Biotech, Inc.

Enrollment

42 participants

Start Date

Jan 21, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment called ACE1831 — a type of engineered immune cell therapy — for adults with a type of blood cancer called B-cell lymphoma (non-Hodgkin's lymphoma) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You have a CD20-positive B-cell lymphoma that has returned or did not respond to at least 2 prior standard treatments - You have at least one measurable tumor - You are generally well enough to carry out normal daily activities (ECOG 0–1, or ECOG 2 with normal protein levels) - Your blood, kidney, liver, and heart function are adequate - Your blood oxygen level is at least 92% at rest **You may NOT be eligible if...** - You have previously received a CD20-targeted gene-modified cell therapy - You had an autologous stem cell transplant within the last 6 weeks, or any allogeneic (donor) stem cell transplant - You have a history of lymphoma in the brain or spine - You have an active serious infection or significant heart disease - You have uncontrolled HIV, active hepatitis B, or hepatitis C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Lymphodepleting agent

DRUGFludarabine

Lymphodepleting agent

DRUGACE1831

Allogeneic gamma delta T (gdT) cell therapy

DRUGObinutuzumab

Anti-CD20 monoclonal antibody


Locations(13)

AdventHealth Orlando

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Norton Cancer Institute

Louisville, Kentucky, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Queen Mary Hospital

Hong Kong, Hong Kong

Kaohsiung Chang-Gung Memorial Hospital

Kaohsiung City, Taiwan

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan

Tamsui MacKay Memorial Hospital

New Taipei City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang-Gung Memorial Hospital

Taoyuan City, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05653271


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