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CAR T-cell Therapy

CLIC-2201 for B-Cell Leukemia

Q: Can you confirm if multiple medical facilities in Canada are conducting this clinical investigation?

Currently, there are 6 clinical trial sites actively enrolling patients. These locations include Ottawa, Toronto, Calgary, and various other places. It is strongly advised to choose the nearest clinic to minimize travel requirements for participants in this study.

Q: What are the main goals being pursued in this research endeavor?

The primary objective of this clinical trial is to determine the maximum tolerated dose (MTD) of CLIC-2201 within approximately 28 days after CAR-T infusion. Secondary endpoints include evaluating the proportion of participants achieving partial remission, which will be assessed on days 28, 90, 180, and 365 to measure the anti-tumor effects of CLIC-2201 treatment over a year. Additionally, overall survival rate within six months post-infusion will also be measured as an indicator of the treatment's anti-tumor activity. Another secondary outcome is assessing the proportion of B-cell <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a> (B-

Q: What are the potential risks and adverse effects of CLIC-2201 on individuals?

Considering that this trial is in Phase 1, indicating limited available data on safety and efficacy, our team at Power rates the safety of CLIC-2201 as a score of 1.

Q: Are there any ongoing efforts to enroll participants for this study at the moment?

According to the information provided on clinicaltrials.gov, this specific trial is not currently seeking participants. The trial was initially posted on May 1st, 2024 and has been most recently updated on January 5th, 2024. Nonetheless, it's worth noting that there are presently numerous other studies actively recruiting patients—specifically, a total of 2876 studies accepting candidates at this time.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years of car-t infusion

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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My disease came back or didn't respond after 2 treatments, a stem cell transplant, or CAR-T therapy.

Select...

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.

Select...

I have been diagnosed with a B-cell cancer.

Select...

I am 18 or older for Cohort A, or between 1-18 years old for Cohort B.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years of car-t infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

Other outcome measures

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 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CLIC-2201Experimental Treatment1 Intervention

A single Intravenous infusion of CLIC-2201 will be given.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

90,487 Total Patients Enrolled

Kevin Hay, MDPrincipal InvestigatorBC Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you confirm if multiple medical facilities in Canada are conducting this clinical investigation?

"Currently, there are 6 clinical trial sites actively enrolling patients. These locations include Ottawa, Toronto, Calgary, and various other places. It is strongly advised to choose the nearest clinic to minimize travel requirements for participants in this study."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary objective of this clinical trial is to determine the maximum tolerated dose (MTD) of CLIC-2201 within approximately 28 days after CAR-T infusion. Secondary endpoints include evaluating the proportion of participants achieving partial remission, which will be assessed on days 28, 90, 180, and 365 to measure the anti-tumor effects of CLIC-2201 treatment over a year. Additionally, overall survival rate within six months post-infusion will also be measured as an indicator of the treatment's anti-tumor activity. Another secondary outcome is assessing the proportion of B-cell acute lymphoblastic leukemia (B-"

Answered by AI

What are the potential risks and adverse effects of CLIC-2201 on individuals?

"Considering that this trial is in Phase 1, indicating limited available data on safety and efficacy, our team at Power rates the safety of CLIC-2201 as a score of 1."

Answered by AI

Are there any ongoing efforts to enroll participants for this study at the moment?

"According to the information provided on clinicaltrials.gov, this specific trial is not currently seeking participants. The trial was initially posted on May 1st, 2024 and has been most recently updated on January 5th, 2024. Nonetheless, it's worth noting that there are presently numerous other studies actively recruiting patients—specifically, a total of 2876 studies accepting candidates at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208735.