Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06208735
PHASE1

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

Sponsor: British Columbia Cancer Agency

View on ClinicalTrials.gov

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.

Official title: CLIC-02: A Phase I Trial of CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-01-02

Completion Date

2027-08-01

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

CLIC-2201

Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-2201 CAR-T cells. All treatments will be delivered intravenously.

Locations (7)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Alberta Children's Hospital

Calgary, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada