Spots Global Cancer Trial Database for Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL
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Trial Identification
Brief Title: Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL
Official Title: Phase I Clinical Trial on the Use of Fresh, Allogeneic, Second-generation CD19-CAR T Cells for Treatment of Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Study ID: NCT06080191
Conditions
Interventions
Study Description
Brief 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).
Detailed Description: This is a phase 1, single-center, non-randomized, open-label, dose-escalation study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of fresh, donor-derived, CD19-directed-second-generation CAR T cells (alloCART) in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL) occurring either after allogeneic hematopoietic stem cell transplantation (alloHSCT) or before alloHSCT, in case of refractory disease and availability of a HLA-fully matched donor.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ospedale Pediatrico Bambino Gesù, Rome, , Italy
Contact Details
Name: Franco Locatelli, MD, PhD
Affiliation: Director Department of Hematology/Oncology and Cell and Gene Therapy
Role: PRINCIPAL_INVESTIGATOR
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