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

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

Trial Details

NCT ID
NCT03765177
Phase
PHASE1 / PHASE2
Sponsor
Ottawa Hospital Research Institute
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • CLIC-1901
Locations (sample)
  • Vancouver, British Columbia, Canada|49.24966,-123.11934
  • Winnipeg, Manitoba, Canada|49.8844,-97.14704
  • Ottawa, Ontario, Canada|45.41117,-75.69812

Key Eligibility Criteria

  • Participant must have relapsed or refractory CD19+ disease as defined by one of the following:
  • a. Relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia as defined by one of the following: i. Second or greater rel…
  • All eligible participants must have documentation of CD19 tumour expression demonstrated in tissue biopsy, bone marrow or peripheral blood within t…
  • Adequate organ function

For full eligibility, visit ClinicalTrials.gov.

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