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

April 1, 2026 updated by: AvenCell Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
    • Baden-Wurttemberg
    • Bavaria
    • Hesse
      • Marburg, Hesse, Germany, 35032
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
    • Saxony
      • Dresden, Saxony, Germany, 01307
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • University of Chicago
        • Contact:
          • Peter Riedell, Ass. Prof.
          • Phone Number: peter.riedell@uchicagomedicine
      • Evanston, Illinois, United States, 60208
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the incidence of dose-limiting toxicities (DLT)
Time Frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
Incidence of DLTs
At the end of cycle 1 (in total 28 days, given no treatment interruptions)
To determine the maximum tolerated dose (MTD)
Time Frame: At the End of Cycle 1 (in total 28 days, given no treatment interruptions)
MTD
At the End of Cycle 1 (in total 28 days, given no treatment interruptions)
Incidence of AEs defined as DLTs
Time Frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
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)
Phase 2: Complete response rate (CRR)
Time Frame: Up to week 13
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Up to 24 months
DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.
Up to 24 months
Pharmacokinetics of Allo-QuadCAR01-T in PB in patients after infusion of Allo-QuadCAR01-T
Time Frame: Up to 24 months
Detection of VCN in blood samples
Up to 24 months
To investigate the impact of Allo-QuadCAR01-T on MRD
Time Frame: Up to 24 months
MRD levels in responding CLL patients
Up to 24 months
To evaluate immunogenicity against Allo-QuadCAR01-T
Time Frame: Up to 24 months
Incidence of ADA1 formation against anti-CD19/CD20 ECD and ADA2 formation against the RevCAR ECD of Allo-QuadCAR01-T
Up to 24 months
To evaluate host immune cell depletion and reconstitution resulting from LD
Time Frame: Up to 24 months
Enumeration of host PB B-cell, T cell, and NK cell numbers
Up to 24 months
Overall Response Rate (ORR)
Time Frame: Up to 24 months
ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma, anti-CLL therapy or local radiotherapy for lymphoma , per the Lugano Classification, as determined by the investigator.
Up to 24 months
Progression-Free Survival (PFS)
Time Frame: Up to 24 months
PFS is defined as the time from Allo-QuadCAR01-T infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 24 months
OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.
Up to 24 months
Time to Next Treatment (TTNT)
Time Frame: Up to 24 months
TTNT is defined as time from Allo-QuadCAR01-T infusion to the start of subsequent new anti-lymphoma, anti-CLL therapy or local radiotherapy for lymphoma.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AvenCell Therapeutics, Inc.

Collaborators

AvenCell Europe GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2026

Primary Completion (Estimated)

April 27, 2029

Study Completion (Estimated)

November 2, 2029

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVC-203-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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