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

Recruiting Phase 1 Interventional Study
B-cell Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
1 – 35
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Bambino Gesù Hospital and Research Institute · Other
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About This Trial

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 Locations
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Eligibility Criteria
Patient Inclusion Criteria: 1. Patients with a diagnosis of CD19 expressing B ALL relapse, and one of the following: 1. Relapse after alloHSCT OR 2. Relapsed/refractory disease, with failure of frontline therapy and at least 2 rescue strategies, including CD19/CD22-directed monoclonal antibo…
Contacts

Franco Locatelli, MD, PhD

+39066859

franco.locatelli@opbg.net

CONTACT

Francesca del Bufalo, MD, PhD

+39066859

francesca.delbufalo@opbg.net

CONTACT