Clinical Trial

CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies

Recruiting Phase 1
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Record status
This record was last updated April 3, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed/refractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion. The primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies. The secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201. Exploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-01-05; most recent amendment 2026-03-30.
Status change: Not Yet Recruiting → Recruiting 2025-01-02
Trial Details
NCT Number NCT06208735
Lead Sponsor British Columbia Cancer Agency
Conditions B-Cell Leukemia, Non-Hodgkin's Lymphoma, B-cell Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Mantle Cell Lymphoma, B-cell Lymphoma
Enrollment 24 participants
Start Date 2025-01-02
Primary Completion 2026-08-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-03