Study of CT1190B CAR-T Cell Treatment for Relapsed or Resistant B-cell Acute Lymphoblastic Leukemia in Patients Aged 12 to 75

What this Trial Is About

Researchers are investigating the safety, effectiveness, and cellular metabolic behavior of ct1190b cells in patients with relapsed or refractory B-cell acute lymphoblastic leukemia B-ALL. This open-label, early phase 1 trial focuses on patients with CD19 andor CD20 positive B-ALL who have not responded to standard treatments or have relapsed. The study aims to better understand how the ct1190b cells work in the body and their potential impacts on this serious form of leukemia. Participants receive ct1190b CAR-T cell injections, which are genetically modified T cells targeting CD19 and CD20 proteins on leukemia cells. The study includes a dose escalation phase with different dosing levels for adults 18 years and adolescentschildren 12-17 years. Adults receive doses from 3.0 to 6.0 x 108 CAR-T cells, while younger participants receive doses based on body weight with limits on total cells infused. Dose adjustments may be made based on safety, effectiveness, and cellular metabolism data throughout the trial. During the study, participants are closely monitored with tests and evaluations over 12 months after cell infusion. Researchers assess adverse events, response rates, remission duration, survival, and gene levels of ct1190b cells at multiple time points. Safety is evaluated mainly within 28 days and throughout the year. Participants undergo regular clinical and laboratory assessments to track treatment effects and side effects. The total study duration includes follow-up to understand long-term outcomes and cellular behavior after treatment.

A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults