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CAR T-cell Therapy

CLIC-1901 CAR-T Therapy for Blood Cancers (CLIC-01 Trial)

Phase 1 & 2
Recruiting
Led By Natasha Kekre, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
a. Relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia as defined by one of the following: i. Second or greater relapse ii. Any relapse after allogeneic stem cell transplantation (SCT) iii. Chemorefractory as defined by not achieving CR after 2 cycles of a standard induction chemotherapy or one cycle of salvage therapy
Participant must have relapsed or refractory CD19+ disease as defined by one of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after car-t cell infusion
Awards & highlights

CLIC-01 Trial Summary

This trial is a study to see if a new treatment for cancer, called CLIC-1901 autologous anti-CD19 Chimeric Antigen Receptor T cells, is safe and effective. The study will enroll 60 participants with relapsed/refractory CD19 positive (CD19+) Acute Lymphoblastic Leukemia (ALL) and non-Hodgkin's Lymphoma (NHL). The treatment will be given as a single infusion of the CAR-T cells.

Who is the study for?
This trial is for adults aged 18-75 with relapsed/refractory CD19+ blood cancers, including certain types of leukemia and lymphoma. Participants must have had a previous relapse or been unresponsive to standard treatments, and show CD19 expression in recent tests. They need good organ function but can't join if they've had gene therapy, certain other conditions or treatments, active infections like HIV/Hepatitis B/C, or are pregnant/nursing.Check my eligibility
What is being tested?
The study is testing CLIC-1901 CAR-T cell therapy on patients with specific blood cancers who haven't responded well to other treatments. It's given as an IV infusion after pre-treatment with drugs to weaken the immune system (lymphodepletion). The first part checks safety/feasibility in 20 people; the second expands to efficacy/safety in a total of 100 participants.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system being weakened by pretreatment drugs and those associated with CAR-T therapies such as fever, difficulty breathing, changes in blood pressure/pulse rate, fatigue, confusion or neurological symptoms.

CLIC-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia has come back or hasn't responded to treatment.
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My cancer has returned or is not responding to treatment and tests positive for CD19.
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I am between 18 and 75 years old.

CLIC-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after car-t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after car-t cell 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
Meeting enrollment targets
Cytokine Release Syndrome
Proportion of participants with complete (CR) or partial response (PR) to CLIC-1901

CLIC-01 Trial Design

1Treatment groups
Experimental Treatment
Group I: CLIC-1901Experimental Treatment1 Intervention
A single Intravenous infusion of CLIC-1901 will be given.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,634 Total Patients Enrolled
Natasha Kekre, MDPrincipal InvestigatorOttawa Hospital Research Isntitute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Research Involvement and EngagementJournal
Partnering with Patients to Get Better Outcomes with Chimeric Antigen Receptor T-cell Therapy: Towards Engagement of Patients in Early Phase Trials
Foster, Madison, Dean A Fergusson, Terry Hawrysh, Justin Presseau, Natasha Kekre, Stuart Schwartz, Gisell Castillo, et al.. 2020. “Partnering with Patients to Get Better Outcomes with Chimeric Antigen Receptor T-cell Therapy: Towards Engagement of Patients in Early Phase Trials”. Research Involvement and Engagement. Springer Science and Business Media LLC. doi:10.1186/s40900-020-00230-5.
BMJ OpenJournal
Navigating Choice in the Face of Uncertainty: Using a Theory Informed Qualitative Approach to Identifying Potential Patient Barriers and Enablers to Participating in an Early Phase Chimeric Antigen Receptor T (CAR-T) Cell Therapy Trial
Castillo, Gisell, Manoj M Lalu, Sarah Asad, Madison Foster, Natasha Kekre, Dean A Fergusson, Terry Hawrysh, et al.. 2021. “Navigating Choice in the Face of Uncertainty: Using a Theory Informed Qualitative Approach to Identifying Potential Patient Barriers and Enablers to Participating in an Early Phase Chimeric Antigen Receptor T (CAR-T) Cell Therapy Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-043929.
TrialsJournal
Hematologists’ Barriers and Enablers to Screening and Recruiting Patients to a Chimeric Antigen Receptor (CAR) T Cell Therapy Trial: A Theory-informed Interview Study
Castillo, Gisell, on behalf of the GO CART team, Manoj Lalu, Sarah Asad, Madison Foster, Natasha Kekre, Dean Fergusson, et al.. 2021. “Hematologists’ Barriers and Enablers to Screening and Recruiting Patients to a Chimeric Antigen Receptor (CAR) T Cell Therapy Trial: A Theory-informed Interview Study”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05121-y.
clinicaltrials.govStudy
CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
2019. "CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03765177.
~5 spots leftby Oct 2024
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