Condition: B-Cell Leukemia · Non-Hodgkin's Lymphoma · B-cell Acute Lymphoblastic Leukemia · Sponsor: British Columbia Cancer Agency
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) assess…
This description comes directly from the study's public registry record.
Kevin Hay, MD · (403) 210-6191 · kevin.hay@bccancer.bc.ca
Narsis Afghari, MSc · (604) 675-4100 · narsis.afghari@bccancer.bc.ca
Always discuss trial participation with your own doctor first.
| Arthur J.E. Child Comprehensive Cancer Centre | Calgary, Alberta, Canada | Recruiting |
| Alberta Children's Hospital | Calgary, Alberta, Canada | Recruiting |
| Vancouver General Hospital | Vancouver, British Columbia, Canada | Recruiting |
| BC Children's Hospital | Vancouver, British Columbia, Canada | Recruiting |
| The Ottawa Hospital - General Campus | Ottawa, Ontario, Canada | Recruiting |
| Princess Margaret Cancer Centre | Toronto, Ontario, Canada | Recruiting |
| The Hospital for Sick Children | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06208735