Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL

This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).

Trial Details

NCT ID

NCT06080191

Phase

PHASE1

Sponsor

Bambino Gesù Hospital and Research Institute

Status

RECRUITING

Cancer Type

Acute Lymphoblastic (ALL) Leukemia

Interventions

CD19-CAR_Lenti_ALLO

Locations (sample)

Rome, Italy, Italy|41.89193,12.51133

Key Eligibility Criteria

Patients with a diagnosis of CD19 expressing B ALL relapse, and one of the following:
Relapse after alloHSCT OR
Relapsed/refractory disease, with failure of frontline therapy and at least 2 rescue strategies, including CD19/CD22-directed monoclonal antibody a…
CD19+ count ≥ 50 cells/mcl and/or Minimal Residual Disease (MRD) ≥ 10\^-4.

For full eligibility, visit ClinicalTrials.gov.

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