Phase III Study of Intravenous CLIC-1901 CAR-T Cell Therapy for Adults with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, and Non-Hodgkins Lymphoma

What this Trial Is About

Researchers are evaluating the safety, feasibility, and effectiveness of CLIC-1901 autologous anti-CD19 CAR-T cells in patients with relapsed or refractory CD19-positive Acute Lymphoblastic Leukemia ALL and Non-Hodgkins Lymphoma NHL. This early phase III trial includes an initial stage focusing on safety and feasibility in 20 participants, followed by an extended stage enrolling up to 100 participants to assess treatment response. The study aims to better understand how this therapy works for participants with these blood cancers. Participants will receive a single intravenous infusion of CLIC-1901 CAR-T cells after undergoing lymphodepletion with cyclophosphamide and fludarabine. The treatment is delivered intravenously, and the study is designed as a two-stage, single-arm, open-label trial. The initial 20 participants will focus on safety and tolerability, and upon successful completion, up to 80 additional participants will be enrolled to evaluate the overall response rate at six months. During the study, participants will be closely monitored for safety, including the occurrence of severe cytokine release syndrome within the first 28 days after infusion. Researchers will assess treatment response at six months and track enrollment progress. Participants must attend study visits for evaluations, including tissue biopsies, blood tests, and clinical assessments. The total duration of participation depends on the stage of enrollment and follow-up requirements, with safety and efficacy outcomes guiding the study progress.

CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies