Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT

Sponsor

Fondazione Matilde Tettamanti Menotti De Marchi Onlus (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03389035

Collaborator

(none)

Enrollment

Locations

Arm

51.3

Anticipated Duration (Months)

10.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia, in Relapse	Biological: CARCIK-CD19	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 20, 2017

Actual Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CARCIK-CD19	Biological: CARCIK-CD19 Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene

Arm

Intervention/Treatment

Experimental: CARCIK-CD19

Biological: CARCIK-CD19

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

Outcome Measures

Primary Outcome Measures

Dose Limiting Toxicities (DLT): [1 month]
rate and severity of the cytokine release syndrome (CRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;