Actively Recruiting
Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
Led by AvenCell Therapeutics, Inc. · Updated on 2026-04-02
178
Participants Needed
13
Research Sites
199 weeks
Total Duration
On this page
Sponsors
A
AvenCell Therapeutics, Inc.
Lead Sponsor
A
AvenCell Europe GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia
- Received at least 2 prior lines of therapy
- ECOG performance status 0-1
- Adequate heart, liver, and kidney function
- HLA B/C match with donor cells
- No active uncontrolled infections
You will not qualify if you...
- Active central nervous system involvement in dose escalation cohorts (may be allowed later with approval)
- Prior CAR-T therapy within 3 months or severe immune-related toxicity from prior CAR-T
- Autologous stem cell transplant within 3 months
- Prior allogeneic stem cell or solid organ transplant
- Previous therapy with dual CD19/CD20 CAR-T
- Severe hypersensitivity to trial agents or similar compounds
- History of graft-versus-host disease or post-transplant lymphoproliferative disorder
- Presence of La/SS-B autoantibodies or related autoimmune diseases
- Other malignancies that may interfere except certain treated skin, prostate, breast cancers, and others in remission for 2 years
- Active viral infections within 1 week or serious bacterial/fungal infections
- Hemorrhagic cystitis
- Active neuro-autoimmune diseases
- Active or residual HBV, HCV, syphilis infections
- Active HIV infection (some history may be allowed with approval)
- Recent neurological or significant cardiac disorders
- Primary immunodeficiency or autoimmune disease requiring systemic treatment within 1 year (unless stable and approved)
- Unresolved grade 2 or higher non-blood toxicity from prior therapy (except mild neuropathy)
- Systemic immunosuppression within 28 days
- Recent lymphoma/CLL therapy 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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
2
Northwestern University
Evanston, Illinois, United States, 60208
Not Yet Recruiting
3
Brown University Health
Providence, Rhode Island, United States, 02903
Not Yet Recruiting
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
6
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
7
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
8
Klinikum der Universität München
Munich, Bavaria, Germany, 81377
Not Yet Recruiting
9
Universitätsklinikum Marburg
Marburg, Hesse, Germany, 35032
Not Yet Recruiting
10
Uniklinikum Erlangen
Essen, North Rhine-Westphalia, Germany, 45147
Not Yet Recruiting
11
Universitätsklinikum Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
12
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
13
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
Research Team
A
Antje Warth, Dr.
CONTACT
M
Markese Sanders
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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