Phase I Study of MB-CART2219.1, a CAR-T Cell Therapy Targeting CD19CD22, for Treating Relapsed or Resistant B-cell Cancers in Adults and Children

What this Trial Is About

Researchers are conducting a Phase I dose finding study to evaluate MB-CART2219.1, a CAR-T cell therapy targeting CD19 and CD22, in adults and children aged 12 to 75 years with relapsed or refractory B-cell malignancies, including lymphoma, chronic lymphocytic leukemia, and pediatric acute lymphoblastic leukemia. This early phase study aims to find a safe and feasible dose for this biological treatment using a 33 design. Participants receive CAR-T cells at different dose levels ranging from 0.25 to 2 million CAR-transduced T cells per kilogram of body weight to determine the best dose. The study evaluates safety and feasibility over six months, focusing on adverse events graded by CTCAE criteria. This dose finding is essential before further testing of treatment effectiveness. During the study, participants undergo regular visits for monitoring, including assessments of their disease and treatment side effects. Researchers track safety outcomes and feasibility over six months and require participants to commit to follow-up visits for up to 15 years to monitor long-term effects as part of gene therapy guidelines. Blood tests and other clinical evaluations will be done to assess response and side effects.

A Phase I Dose Finding Study of MB-CART2219.1