Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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