Carlotta01 is a national, open-label, single-arm Phase I dose-escalation trial investigating autologous BCMA-targeting CAR T-cell therapy (MDC-CAR-BCMA001) in patients with relapsed and refractory B-cell malignancies. The primary objective is to establish the safest and maximum tolerated dose (MTD) and evaluate dose-limiting toxicities (DLTs). Eligible patients are adults with relapsed/refractory Multiple Myeloma (MM) or DLBCL who are not candidates for available standard of care.The intervention involves a single intravenous infusion of MDC-CAR-BCMA001 following lymphodepleting chemotherapy. Important secondary endpoints include the Overall Response Rate (ORR), Progression-Free Survival (PFS), and the pharmacokinetics of the CAR T-cells.
Carlotta01 is an early-phase Phase I trial from Germany investigating a new type of immunotherapy for patients with blood or lymph gland cancer. The primary goal is to determine the safety and the maximum tolerated dose of special T-cells (BCMA-CAR T-cells). These T-cells are manufactured from the patient's own immune cells and modified to specifically target the cancer cells. This study is recruiting adult patients with Multiple Myeloma or certain lymphomas whose disease has returned or is resistant to previous treatments. Participants will receive a single infusion of these special T-cells.
