Safety and Efficacy of hCD1a-CAR T (OC-1) Therapy in Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma

What this Trial Is About

Researchers are evaluating the safety and efficacy of a new treatment called CD1a-CAR T therapy for patients with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic T-cell lymphoma. This is a first-in-human, exploratory, open-label, single-arm, multicenter study focused on patients who have not responded well to standard treatments. The study is sponsored by OneChain Immunotherapeutics and is a Phase 1 trial aiming to understand how this therapy works and its safety profile. The treatment involves using a patient's own T-cells, which are collected from their blood, expanded, and genetically modified with a lentivirus to express a CD1a chimeric antigen receptor. These modified T-cells are then given back to the patient through intravenous infusion in escalating doses to find the safest and most effective dose. This dose-escalation approach helps researchers carefully monitor responses and side effects as the dose increases. Participants will be closely monitored for one year after receiving the infusion. Researchers will track adverse events, including severe immune reactions like cytokine release syndrome and neurotoxicity, as well as treatment-related deaths and specific side effects such as skin reactions. They will also assess how well the immune system remains balanced, measure remission rates, disease progression, survival, and the persistence of the infused cells. The study involves detailed follow-up visits and evaluations to gather this information over the year following treatment.

Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL