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CAR T-cell Therapy
CLIC-2201 for B-Cell Lymphoma
Phase 1
Waitlist Available
Led By Kevin Hay, MD
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Refractory or relapsed disease, defined as relapse or refractory disease after at least 2 lines of therapy, any relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT), or any relapse after CAR-T cell therapy
Adequate organ function at enrolment, defined as left ventricular ejection fraction (LVEF) ≥40%, creatinine clearance using Cockcroft-Gault equation of > 30 mL/min, AST/ALT < 5X upper limit of normal (ULN), bilirubin < 2X ULN, and no evidence or history of liver cirrhosis
Must not have
Any uncontrolled or serious active infection at the time of enrolment
Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years of car-t infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment called CLIC-2201 for people with certain types of cancer. Participants will have their own immune cells collected and modified in a lab to attack cancer cells. They
Who is the study for?
This trial is for people with certain types of B-cell blood cancers that have come back or haven't responded to treatment. Participants must be able to undergo a procedure to collect their T cells, receive high-dose chemotherapy, and then get an infusion of the CAR-T cell therapy CLIC-2201.
What is being tested?
The study tests different doses of CLIC-2201, a new type of personalized immune cell therapy targeting CD22 on cancer cells. It involves collecting patients' own T cells, modifying them in the lab into CAR-T cells, and infusing them back after chemotherapy.
What are the potential side effects?
Potential side effects include reactions related to the infusion such as fever and chills (cytokine release syndrome), low blood counts from chemotherapy (lymphodepletion), increased risk of infections, and possibly neurological symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease came back or didn't respond after 2 treatments, a stem cell transplant, or CAR-T therapy.
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My heart, kidneys, and liver are functioning well enough for the trial.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with a B-cell cancer.
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I am 18 or older for Cohort A, or between 1-18 years old for Cohort B.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious or uncontrolled infections.
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I am currently being treated for GVHD with medication.
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I have a genetic condition linked to bone marrow failure.
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I am on immunosuppressive drugs for my autoimmune disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years of car-t infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years of car-t infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Defining the maximum tolerated dose (MTD) of CLIC-2201
Proportion of participants who experienced any SAEs to define the safety of CLIC-2201
Proportion of participants who experienced any grade of AEs to define the safety of CLIC-2201
+3 moreSecondary study objectives
Median time from enrollment to CLIC-2201 infusion
Median time from enrollment to disease progression that prevents CLIC-2201 infusion.
Median time from enrollment to leukapheresis
+10 moreOther study objectives
Clonal typing and gene expression profiling of the CLIC-2201 infusion product. (Single cell RNA-sequencing)
Evaluating the health-related quality of life
Evaluating the quality of life
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CLIC-2201Experimental Treatment1 Intervention
A single Intravenous infusion of CLIC-2201 will be given.
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
176 Previous Clinical Trials
95,204 Total Patients Enrolled
Kevin Hay, MDPrincipal InvestigatorBC Cancer