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

NCT06080191 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-02

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

CD19-CAR_Lenti_ALLO

Biological/Vaccine: CD19-CAR\_Lenti\_ALLO A single infusion of CD19-CAR\_Lenti\_ALLO on Day 0

Sponsors & Collaborators

  • Bambino Gesù Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Franco Locatelli, MD, PhD · Director Department of Hematology/Oncology and Cell and Gene Therapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-28
Primary Completion
2026-06-30
Completion
2041-06-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080191 on ClinicalTrials.gov