Actively Recruiting
CLIC-02: Phase I Trial of CLIC-2201 CAR-T Cells for Relapsed/Refractory B Cell Malignancies
Led by British Columbia Cancer Agency · Updated on 2026-04-03
24
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CLIC-2201, an autologous CD22-targeting CAR-T cell therapy, in a phase I trial for people with relapsed or refractory B cell malignancies. The study aims to determine the safety, tolerability, and maximum tolerated dose of CLIC-2201, while also assessing its feasibility, anti-tumor activity, pharmacokinetics, immune responses, biomarkers, and quality of life over up to 15 years. The trial includes adult and pediatric/young adult participants with various aggressive B cell cancers. Participants will undergo leukapheresis to collect their own T cells, which are then modified and expanded in a lab to create CLIC-2201. Before receiving the infusion, they will have lymphodepleting chemotherapy with cyclophosphamide and fludarabine to help the CAR-T cells work effectively. The CLIC-2201 is infused intravenously. The dose will be adjusted using a 3+3 design to identify the best tolerated dose, with adults treated first at each level before pediatric participants. Participants will stay in the hospital for at least 7 days after infusion for close monitoring. During the study, participants will have scheduled visits for up to two years and annual follow-ups up to 15 years to assess safety, side effects, response to treatment, immune profiles, and quality of life. Researchers will monitor various safety outcomes including cytokine release syndrome and neurological events. The trial involves tests like biopsies, blood samples, and clinical assessments to track the effects of the therapy and participant health throughout the study.
CONDITIONS
Brief 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 diffuse large B-cell lymphoma, high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, aggressive transformed B cell lymphoma, or mantle cell lymphoma.
- Participants with relapsed or refractory disease after at least 2 lines of therapy, or relapse after hematopoietic cell transplant or prior CAR-T therapy.
- Adequate organ function including LVEF 6%, creatinine clearance >30 mL/min, liver enzymes below 5 times the upper limit, and no liver cirrhosis.
- ECOG performance status 2 or Karnofsky score 50%.
- Females of child-bearing potential and sexually active males must agree to use effective contraception through one year post-treatment.
- Willingness to undergo tumor biopsy if accessible.
- Pediatric/young adult participants aged 1 to 39 years with relapsed or refractory B cell acute lymphoblastic leukemia.
- Pediatric participants must have documented CD22 tumor expression within 6 months prior to screening.
- Adequate organ function including LVEF 45%, creatinine clearance >30 mL/min, liver enzymes below 5 times the upper limit, and no liver cirrhosis.
- Karnofsky or Lansky score 50%.
- Agreement to use effective contraception through one year post-treatment.
- Willing to undergo bone marrow biopsy at enrollment.
- Written informed consent provided (parent or guardian consent with assent for minors).
You will not qualify if you...
- Uncontrolled or serious active infection at enrollment.
- Active autoimmune disease requiring immunosuppressive therapy within 4 weeks.
- Live vaccine within 6 weeks prior to enrollment.
- Active graft versus host disease needing systemic immunosuppressive therapy within 4 weeks.
- Diagnosis of primary central nervous system lymphoma.
- Recent treatments before leukapheresis including allogeneic or autologous hematopoietic cell transplant, CD19 CAR-T infusion, donor lymphocyte infusion within 3 months.
- Bendamustine within 6 months, investigational agents within 30 days or 5 half-lives.
- Systemic corticosteroids above specified doses within 7 days before leukapheresis.
- Immunosuppressive therapies within 4 weeks unless for B cell malignancy.
- Oral chemotherapy agents within 5 half-lives except BTK inhibitors in mantle cell lymphoma.
- Other malignancies treated within past 2 years except certain skin or cervical carcinomas.
- Genetic syndromes associated with bone marrow failure or immunodeficiency.
- Active hepatitis B or C confirmed by PCR.
- HIV infection.
- Allergies to fludarabine, cyclophosphamide, gentamycin, or derivatives.
- Not meeting minimum weight for planned dose level.
- Pregnant or nursing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility confirmation and consent
Duration - Approximately 8 days for manufacturing
Participants undergo leukapheresis, a procedure to collect white blood cells for manufacturing the CLIC-2201 CAR-T cells. The collected cells are shipped and processed to produce the treatment.
1 visit for leukapheresis
Duration - 2 days
Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide to prepare the body for CLIC-2201 infusion by reducing existing immune cells.
2 consecutive days of intravenous chemotherapy
Duration - Minimum of 7 days in hospital
Participants receive a single intravenous infusion of autologous CLIC-2201 CAR-T cells and are admitted to the hospital for close monitoring of side effects and complications.
Continuous in-patient monitoring for at least 7 days
Duration - Up to 15 years post-infusion
Participants attend scheduled outpatient clinic visits for ongoing monitoring of safety and response to treatment.
Visits on days 10, 14, 21, 28, 60, 90, 180, 365, 547, 730, and annual visits thereafter
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
N
Narsis Afghari, MSc
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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