Phase 1b2 Study of CTD402 CAR T Cell Therapy for Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma in Patients Aged 12 and Older

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CTD402 UCART in patients aged 12 and older with relapsed or refractory T-cell acute lymphoblastic leukemia T-ALL or lymphoblastic lymphoma T-LBL. This open-label, single-arm, multi-center study includes adolescents and adults and aims to establish the recommended dose and confirm treatment effects. The study is sponsored by BIOHENG THERAPEUTICS US LLC and includes detailed safety and response evaluations. Participants will receive a single infusion of CTD402 after a lymphodepletion period within 7 days prior to treatment. The study includes screening lasting up to 2 weeks, followed by the treatment day and a primary follow-up period lasting up to 2 years. After the initial study period, participants will be enrolled in a separate long-term follow-up protocol for up to 15 years to monitor survival, toxicity, relapse, and secondary malignancies. During the study, participants will have assessments for tumor response using NCCN criteria for T-ALL and Lugano 2014 criteria for T-LBL. Safety monitoring will be conducted for 24 months, including evaluation of the cellular pharmacokinetic profile of CTD402. The study involves regular clinical visits, laboratory testing, and monitoring for adverse events. Participant involvement is planned for up to 2 years with extended follow-up to track long-term outcomes.

A Study of CTD402 in T-ALL/LBL Patients