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

NCT ID: NCT07284433

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2029-11-02

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cyclophosphamide (Non-IMP, Lymphodepletion)

Intervention Type: OTHER

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

Fludarabine (Non-IMP, Lymphodepletion)

Intervention Type: OTHER

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

Allo-QuadCAR01-T

Intervention Type: DRUG

Single dose IV infusion on Day 1

Interventions

Cyclophosphamide (Non-IMP, Lymphodepletion)

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

Intervention Type: OTHER

Fludarabine (Non-IMP, Lymphodepletion)

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

Intervention Type: OTHER

Allo-QuadCAR01-T

Single dose IV infusion on Day 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults 18 years or older.
• Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
• Must have received at least 2 prior lines of therapy.
• ECOG performance status 0-1 (able to carry out daily activities).
• Adequate organ function (heart, liver, kidneys).
• HLA B/C match with donor cells.
• No active uncontrolled infections.

Exclusion Criteria

• Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval.
• Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T.
• Autologous stem cell transplant within 3 months.
• Prior allogeneic stem cell transplant or solid organ transplant.
• Prior therapy with dual CD19/CD20 CAR-T.
• Severe hypersensitivity to trial agents or similar compounds.
• History of GvHD or post-transplant lymphoproliferative disorder.
• Presence of La/SS-B autoantibodies or related autoimmune diseases.
• Other malignancy that may interfere with trial, except:

• Curatively treated basal/squamous skin cancer or cervical carcinoma in situ
• Low-grade, early-stage prostate cancer (Gleason ≤6, Stage 1-2) with no therapy needed
• Adjuvant endocrine therapy for non-metastatic breast cancer (≥2 years)
• Any other curatively treated malignancy in remission ≥2 years
• Active viral infection within 1 week of screening, or serious bacterial/fungal infection.
• Hemorrhagic cystitis.
• Active neuro-autoimmune disease (e.g., MS, Guillain-Barré, ALS).
• Active or residual HBV, HCV, or syphilis.
• Active HIV. History of HIV may be eligible with Sponsor approval if:
• Neurological disorders within 6 months (e.g., stroke, dementia, Parkinson's, cerebellar disease, CNS autoimmune disease).
• Significant cardiac disease within 6 months (e.g., MI, stent, unstable angina).
• Primary immunodeficiency or autoimmune disease requiring systemic treatment within 1 year (unless stable and Sponsor-approved).
• Unresolved ≥Grade 2 non-hematologic toxicity from prior therapy (except neuropathy up to Grade 2).
• Systemic immunosuppression within 28 days.
• Last systemic lymphoma/CLL therapy (standard or investigational) within 28 days or 5 half-lives.
• Major surgery within 14 days.
• Local radiation within 28 days.
• Live vaccination within 28 days.
• Pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AvenCell Europe GmbH

INDUSTRY

Sponsor Role: collaborator

AvenCell Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen

Erlangen, Bavaria, Germany

Klinikum der Universität München

Munich, Bavaria, Germany

Universitätsklinikum Marburg

Marburg, Hesse, Germany

Universitätsklinikum Dresden

Dresden, Saxony, Germany

Charité Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Central Contacts

Markese Sanders

Role: CONTACT

avc-203-01@avencell.com

617-941-7468

Antje Warth, Dr.

Role: CONTACT

avc-203-01@avencell.com

Facility Contacts

Andreas Viardot, MD

Role: primary

Stephan Metzelder, MD

Role: primary

Frederik Damm, MD

Role: primary

Other Identifiers

AVC-203-01

Identifier Type: -

Identifier Source: org_study_id