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

NCT07284433 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AVC-203-01
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 13

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

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

Outcome Measures

Primary Outcomes (4)

• Incidence of AEs defined as DLTs

  Incidence and intensity of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), tumor lysis syndrome, and graft versus host disease (GvHD), which will be graded according to widely accepted specialized criteria

  At the end of cycle 1 (in total 28 days, given no treatment interruptions)

• To determine the maximum tolerated dose (MTD)

  MTD

  At the End of Cycle 1 (in total 28 days, given no treatment interruptions)

• To determine the incidence of dose-limiting toxicities (DLT)

  Incidence of DLTs

  At the end of cycle 1 (in total 28 days, given no treatment interruptions)

• Phase 2: Complete response rate (CRR)

  Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.

  Up to week 13

Secondary Outcomes (9)

• Pharmacokinetics of Allo-QuadCAR01-T in PB in patients after infusion of Allo-QuadCAR01-T

  Up to 24 months

• To investigate the impact of Allo-QuadCAR01-T on MRD

  Up to 24 months

• To evaluate immunogenicity against Allo-QuadCAR01-T

  Up to 24 months

• To evaluate host immune cell depletion and reconstitution resulting from LD

  Up to 24 months

• Overall Response Rate (ORR)

  Up to 24 months

Study Arms (1)

Allo-QuadCAR01-T

EXPERIMENTAL

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.

Other: Cyclophosphamide (Non-IMP, Lymphodepletion); Other: Fludarabine (Non-IMP, Lymphodepletion); Drug: Allo-QuadCAR01-T

Interventions

Allo-QuadCAR01-T DRUG

Single dose IV infusion on Day 1

Allo-QuadCAR01-T

Cyclophosphamide (Non-IMP, Lymphodepletion) OTHER

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

Allo-QuadCAR01-T

Fludarabine (Non-IMP, Lymphodepletion) OTHER

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

Allo-QuadCAR01-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AvenCell Therapeutics, Inc.: lead
• AvenCell Europe GmbH: collaborator

Study Sites (13)

University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

NOT YET RECRUITING

Brown University Health

Providence, Rhode Island, 02903, United States

NOT YET RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinikum der Universität München

Munich, Bavaria, 81377, Germany

NOT YET RECRUITING

Universitätsklinikum Marburg

Marburg, Hesse, 35032, Germany

NOT YET RECRUITING

Uniklinikum Erlangen

Essen, North Rhine-Westphalia, 45147, Germany

NOT YET RECRUITING

Universitätsklinikum Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Leukemia; Lymphoma

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Antje Warth, Dr.

CONTACT

0493514466450; avc-203-01@avencell.com

Markese Sanders

CONTACT

617-941-7468; avc-203-01@avencell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial is structured in three parts: Phase Ia uses a dose-escalation approach to find a safe starting dose of Allo-QuadCAR01-T. Phase Ib expands testing at the selected dose in patients with diffuse large B-cell lymphoma (DLBCL) and possibly other subtypes to confirm safety and early effectiveness. Phase II focuses on a larger group of DLBCL patients to measure how well the treatment works at the recommended dose. All participants receive a single infusion of the therapy after a short course of chemotherapy to prepare their immune system. Patients are closely monitored for 13 weeks, then every three months for two years, with an additional long-term follow-up lasting up to 15 years.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 16, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): April 27, 2029
• Study Completion (Estimated): November 2, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

DE (8); US (5)