Ireland
--:--IST
Recruiting Phase 1/2

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

NCT07284433 · tracked via the Priya Life Science USA tracker
Sponsor
AvenCell Therapeutics, Inc
Phase
Phase 1/2
Started
2026-01-06
Last updated
2026-08-28

Condition(s) studied

Lymphoma Diffuse Large B-cellLeukemia and LymphomaLeukemia RelapseLymphoma Receiving CAR-T Therapy

Investigational drug(s) / intervention(s)

Cyclophosphamide (Non-IMP, Lymphodepletion)Fludarabine (Non-IMP, Lymphodepletion)Allo-QuadCAR01-T →

Cyclophosphamide (Non-IMP, Lymphodepletion): Intravenous infusion over 3 days (d-5 to d-3)

Fludarabine (Non-IMP, Lymphodepletion): Intravenous infusion over 3 days (d-5 to d-3)

Allo-QuadCAR01-T: Single dose IV infusion on Day 1

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of AEs defined as DLTs — 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
  • To determine the maximum tolerated dose (MTD) — At the End of Cycle 1 (in total 28 days, given no treatment interruptions)
    MTD
  • To determine the incidence of dose-limiting toxicities (DLT) — At the end of cycle 1 (in total 28 days, given no treatment interruptions)
    Incidence of DLTs
  • Phase 2: Complete response rate (CRR) — 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.

Trial sites (13)

FacilityCityRegionStatus
University of Chicago Chicago Illinois Not Yet Recruiting
Northwestern University Evanston Illinois Not Yet Recruiting
Brown University Health Providence Rhode Island Not Yet Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Not Yet Recruiting
Universitätsklinikum Ulm Ulm Baden-Wurttemberg Recruiting
Universitätsklinikum Erlangen Erlangen Bavaria Recruiting
Klinikum der Universität München Munich Bavaria Recruiting
Universitätsklinikum Marburg Marburg Hesse Not Yet Recruiting
Uniklinikum Erlangen Essen North Rhine-Westphalia Not Yet Recruiting
Universitätsklinikum Dresden Dresden Saxony Recruiting
Charité Universitätsmedizin Berlin Berlin Germany Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284433 on ClinicalTrials.gov ↗ ← All trials in the USA