RecruitingPhase 1Phase 2NCT07284433

Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies

A Single-arm, Multicenter, Open-label, Phase I/II Trial of Allo-QuadCAR01-T, an Allogeneic CAR-T-cell Therapy Targeting CD19 and CD20, for the Treatment of Relapsed or Refractory B-cell Malignancies


Sponsor

AvenCell Therapeutics, Inc.

Enrollment

178 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs. It targets two proteins, CD19 and CD20, to lower the chance of relapse and uses gene editing to make it safer. The trial has three parts: first to find a safe dose, then to confirm it, and finally to test how well it works in patients with diffuse large B-cell lymphoma (DLBCL). Patients will get one infusion after chemotherapy to prepare their body. The main goal is to check safety and see how many patients have a complete response by Week 13. About 160 patients will take part, and researchers will follow them for up to 15 years.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing Allo-QuadCAR01-T, an off-the-shelf CAR-T cell therapy that targets two proteins (CD19 and CD20) found on cancer cells, in patients with relapsed or refractory B-cell blood cancers. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL) - You have received at least 2 prior lines of treatment - Your performance status is 0 or 1 (able to carry out normal daily activities) - Your heart, liver, and kidneys are functioning adequately - Your tissue type (HLA) matches the donor cell product **You may NOT be eligible if...** - Your cancer has spread to the central nervous system (in early dose-escalation cohorts) - You received another CAR-T therapy within the past 3 months or had a severe immune reaction to prior CAR-T - You had an autologous stem cell transplant within the past 3 months - You have had a prior allogeneic stem cell transplant or solid organ transplant - You previously received a dual CD19/CD20 CAR-T therapy 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

OTHERCyclophosphamide (Non-IMP, Lymphodepletion)

Intravenous infusion over 3 days (d-5 to d-3)

OTHERFludarabine (Non-IMP, Lymphodepletion)

Intravenous infusion over 3 days (d-5 to d-3)

DRUGAllo-QuadCAR01-T

Single dose IV infusion on Day 1


Locations(13)

University of Chicago

Chicago, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Brown University Health

Providence, Rhode Island, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Klinikum der Universität München

Munich, Bavaria, Germany

Universitätsklinikum Marburg

Marburg, Hesse, Germany

Uniklinikum Erlangen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Dresden

Dresden, Saxony, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

View Full Details on ClinicalTrials.gov

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NCT07284433


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