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

Fondazione Matilde Tettamanti Menotti De Marchi Onlus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Lymphoblastic Leukemia, in Relapse

Treatments: Biological: CARCIK-CD19

Study type: Interventional

Funder types: Other

Identifiers

NCT03389035

FT01CARCIK

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No 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;

Exclusion criteria

• Patients with GVHD Grades II-IV;
• Any cell therapy in the last 30 days;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 1 patient group

CARCIK-CD19

Experimental group

Treatment:

Biological: CARCIK-CD19