Off-the-shelf CAR-T Allo-QuadCAR01-T targeting CD19 and CD20 for relapsed or refractory B‑cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Allo-QuadCAR01-T is a gene-edited, donor-derived CAR-T product designed to target both CD19 and CD20 to reduce relapse risk and improve safety. The trial has three parts: dose escalation to find a safe dose, dose confirmation, and a phase focused on efficacy in diffuse large B-cell lymphoma. Participants receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by a single infusion of the allogeneic CAR-T product and are monitored for safety and tumor response. About 160 adults will be enrolled with follow-up visits extending up to 15 years for long-term outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sarah Cannon Research Institute
  Nashville, Tennessee, United States Recruiting
• Universitätsklinikum Ulm
  Ulm, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Erlangen
  Erlangen, Bavaria, Germany Recruiting
• Klinikum der Universität München
  Munich, Bavaria, Germany Recruiting
• Universitätsklinikum Dresden
  Dresden, Saxony, Germany Recruiting
• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Antje Warth, Dr.
• Email: avc-203-01@avencell.com
• Phone: 0493514466450

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.