RecruitingPhase 1Phase 2NCT03765177

CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies

Canadian-Led Immunotherapies in Cancer: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies


Sponsor

Ottawa Hospital Research Institute

Enrollment

60 participants

Start Date

Oct 16, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators propose an early phase study defined as a phase I/II trial assessing safety, feasibility and efficacy of CLIC-1901 autologous anti-CD19 Chimeric Antigen Receptor T cells (CAR-T) cells for participants with relapsed/refractory CD19 positive (CD19+) Acute Lymphoblastic Leukemia (ALL) and non-Hodgkin's Lymphoma (NHL). The Initial Stage of the study (n=20 participants) will focus on feasibility and safety while the Extended Stage will include all participants enrolled in the study (n=additional 80 participants for a total of 100) and will focus on efficacy and safety outcomes. In the proposed trial, we will administer our CAR-T cell product to these participants as a single infusion. Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-1901 CAR-T cells. All treatments will be delivered intravenously.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a CAR-T cell therapy called CLIC-1901 — immune cells that are re-engineered to recognize and destroy cancer cells carrying the CD19 protein — for people with blood cancers that have returned or stopped responding to prior treatment. **You may be eligible if...** - You have CD19-positive blood cancer (such as B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, or B-cell non-Hodgkin lymphoma) that has relapsed or is refractory - You have had at least 2 relapses, relapsed after a bone marrow transplant, or did not achieve remission after standard treatment - You are in adequate health to receive the therapy - You are 18 years or older **You may NOT be eligible if...** - Your cancer does not carry the CD19 protein marker - You have active, uncontrolled infections - You have had severe reactions to CAR-T therapy before - You have uncontrolled autoimmune disease or serious organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCLIC-1901

Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-1901 CAR-T cells. All treatments will be delivered intravenously.


Locations(3)

Vancouver General Hospital

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

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NCT03765177


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