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.
The investigators have designed a two-stage, single-arm, open-label early phase study to determine the safety and efficacy of CLIC-1901 cell therapy in patients with CD19+ ALL and NHL. The primary objective in the initial stage of 20 participants will be to evaluate the feasibility of our protocol and the safety and tolerability of infusing autologous CLIC-1901 cells into patients with relapsed/refractory CD19+ ALL or NHL. Once 20 participants have been treated and the treatment is deemed safe, up to 80 more participants will be enrolled in an extension stage where the primary objective will be overall response rate (defined as complete or partial response) at 6 months after CLIC-1901 infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Vancouver General Hospital
Vancouver, British Columbia, Canada
RECRUITINGCancerCare Manitoba
Winnipeg, Manitoba, Canada
NOT_YET_RECRUITINGThe Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
RECRUITINGProportion of participants experiencing either Grade 3 or 4 cytokine release syndrome.
Grade 3 or 4 neurological toxicity, other Grade 3 or 4 toxicity (by CTCAE 4.03) or non-relapse related death.
Time frame: Within the first 28 days of CAR-T infusion
Proportion of participants with complete (CR) or partial response (PR) to CLIC-1901
Complete response, partial response and disease progression reviewed 6 months after CAR-T cell infusion
Time frame: 6 months after CAR-T cell infusion
Meeting enrollment targets
The feasibility outcome has been met 20 participant in 12 months - currently in next phase and on track to finish on or before October 2024
Time frame: First 20 participants within 12 months and next 80 participants within 4 years of opening the second stage.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.