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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide (Non-IMP, Lymphodepletion) — OTHER
  Intravenous infusion over 3 days (d-5 to d-3)
• Fludarabine (Non-IMP, Lymphodepletion) — OTHER
  Intravenous infusion over 3 days (d-5 to d-3)
• Allo-QuadCAR01-T — DRUG
  Single dose IV infusion on Day 1

Study Details

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.

Key Dates

Start date

Jan 6, 2026

Status verified

Apr 2026

Primary completion

Apr 27, 2029

Completion

Nov 2, 2029

Study Design

Enrollment

178 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Allo-QuadCAR01-T
  Phase Ia (Escalation): Participants with relapsed or refractory B-cell malignancies will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T. Phase Ib (Expansion): After dose escalation, additional participants with relapsed or refractory B-cell lymphoma will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T at one or more tolerable dose levels from Phase Ia. Phase II: Participants with relapsed or refractory DLBCL will receive lymphodepleting chemotherapy, followed by a single infusion of Allo-QuadCAR01-T at the recommended Phase II dose. The primary endpoint is complete response rate at Week 13, with secondary endpoints including duration of response, progression-free survival, and overall survival.

Primary Outcome Measure

Incidence of AEs defined as DLTs [ Time Frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions) ]

Central Contacts

• Antje Warth, Dr.
  0493514466450
  [email protected]
• Markese Sanders
  617-941-7468
  [email protected]

Locations (5)

Find similar trials in Chicago, IL

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