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.
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).
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.
AvenCell Therapeutics, Inc.
Lead sponsor
AvenCell Europe GmbH
Collaborator