Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or … (NCT07284433) | Clinical Trial Compass
RecruitingPhase 1/2
Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
United States, Germany178 participantsStarted 2026-01-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of AEs defined as DLTs
Timeframe: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
2
To determine the maximum tolerated dose (MTD)
Timeframe: At the End of Cycle 1 (in total 28 days, given no treatment interruptions)
3
To determine the incidence of dose-limiting toxicities (DLT)
Timeframe: At the end of cycle 1 (in total 28 days, given no treatment interruptions)