Trial | NCT03389035  Report issue

Title

Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    21
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Study Started
Dec 20
2017
Primary Completion
Mar 31
2021
Study Completion
Mar 31
2022
Anticipated
Last Update
Feb 04
2022

Biological CARCIK-CD19

Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene

CARCIK-CD19 Experimental

Criteria 

Inclusion Criteria:

Children (1-17) and adults (18-75 years old);
Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
No longer taking immunosuppressive agents for at least 30 days prior to enrollment;

Exclusion Criteria:

Patients with GVHD Grades II-IV;
Any cell therapy in the last 30 days;
No Results Posted