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

NCT07284433 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Lymphoma Diffuse Large B-cell
  • Leukemia and Lymphoma
  • Leukemia Relapse
  • Lymphoma Receiving CAR-T Therapy

Interventions

OTHER

Cyclophosphamide (Non-IMP, Lymphodepletion)

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

OTHER

Fludarabine (Non-IMP, Lymphodepletion)

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

DRUG

Allo-QuadCAR01-T

Single dose IV infusion on Day 1

Sponsors & Collaborators

  • AvenCell Europe GmbH

    collaborator INDUSTRY

  • AvenCell Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-06
Primary Completion
2029-04-27
Completion
2029-11-02
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

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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 NCT07284433 on ClinicalTrials.gov