NCT07284433

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: AvenCell Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2026-01-06
• Primary completion: 2029-04-27
• Completion: 2029-11-02
• First posted: 2025-12-16
• Last updated: 2026-04-02

Locations

13 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study