Actively Recruiting
CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
Led by British Columbia Cancer Agency · Updated on 2026-04-03
24
Participants Needed
7
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with relapsed or refractory B cell lymphoma (including DLBCL, high grade B cell lymphoma, PMBCL, transformed lymphoma, mantle cell lymphoma)
- Pediatric and young adult participants aged 1 to 39 years with relapsed or refractory B cell acute lymphoblastic leukemia
- Relapsed or refractory disease after at least 2 lines of therapy, or relapse after hematopoietic cell transplantation or CAR-T therapy
- Adequate organ function including LVEF 40% (adults) or 45% (pediatrics), creatinine clearance >30 mL/min, and liver function tests within specified limits
- ECOG performance status 2 or Karnofsky/Lansky score 50%
- Agreement to use highly effective contraception through at least one year post-treatment
- Willingness to undergo tumor biopsy (cohort A) or bone marrow biopsy (cohort B) as applicable
You will not qualify if you...
- Uncontrolled or serious active infections at enrollment
- Active autoimmune disease requiring immunosuppressive therapy within 4 weeks
- Live vaccine within 6 weeks prior to enrollment
- Active graft versus host disease requiring systemic immunosuppressive therapy within 4 weeks
- Diagnosis of primary central nervous system lymphoma
- Recent treatments before leukapheresis including hematopoietic cell transplantation, CD19 CAR-T, donor lymphocyte infusion, bendamustine, investigational agents, corticosteroids, immunosuppressive therapies, or certain chemotherapy agents within specified timeframes
- Concurrent or recent other malignancies except treated carcinoma in situ
- Genetic syndromes associated with bone marrow failure or immunodeficiency
- Active hepatitis B or C infection or HIV infection
- Allergies to fludarabine, cyclophosphamide, gentamycin or derivatives
- Not meeting minimum weight for dose level
- Pregnant or nursing
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
2
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
3
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
4
BC Children's Hospital
Vancouver, British Columbia, Canada
Actively Recruiting
5
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Actively Recruiting
7
The Hospital for Sick Children
Toronto, Ontario, Canada
Actively Recruiting
Research Team
K
Kevin Hay, MD
CONTACT
N
Narsis Afghari, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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