Study of CTA101 UCAR-T Cell Injection for Patients Aged 3 to 70 with Relapsed or Refractory CD19 B-line Blood Cancers

What this Trial Is About

Researchers are evaluating CTA101 UCAR-T cell injection in patients who have relapsed or refractory CD19 B-line hematological malignancies, including B-cell acute lymphoblastic leukemia B-ALL and B-cell non-Hodgkin lymphoma B-NHL. This early phase 1, single-arm, open-label study aims primarily to explore the safety of the treatment, focusing especially on dose-related safety concerns. The study will enroll 72 patients divided into two groups of 36, with dosing levels guided by previous clinical trials of similar products. Participants will receive CTA101 UCAR-T cells via intravenous infusion. The study uses a standard 33 dose escalation design with two dose levels to determine safe dosing. This single-center study does not include a control group and monitors patients closely following infusion. Treatment-emergent adverse events will be tracked for up to 2 years to assess safety. During the study, participants will undergo regular assessments including monitoring for dose-limiting toxicities within 28 days after infusion and tracking adverse events over 2 years. Researchers will also measure response outcomes such as minimal residual disease negative overall response rate, event-free survival, overall response rate, and overall survival at various time points up to 24 months. Additional evaluations for tumor control in B-NHL patients will be conducted. Eligibility includes lab tests, heart function evaluation, infection status, and performance status. The total study duration extends to at least 2 years after treatment infusion.

A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy