Open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing Anti-CD22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Relapsed or refractory B-cell Acute Lymphoblastic Leukemia

Dose escalation Phase: Incidence, nature and severity of adverse events and serious adverse events (SAEs); Incidence, nature, and severity of adverse events and SAEs associated with lymphodepletion, Dose Escalation phase: Proportion of patients in each dose level cohort with dose-limiting toxicity during the DLT observation period, Dose expansion phase: Incidence, nature and severity of adverse events and serious adverse events (SAEs); Incidence, nature, and severity of adverse events and SAEs associated with lymphodepletion

Dose Escalation phase: Investigator assessed overall response rate (ORR) [complete response + complete response CR with incomplete hematologic recovery +complete response with partial hematologic recovery [CR+CRi+ CRh]) according to the Response criteria for Acute Lymphoblastic Leukemia (ALL) and Investigator assessed rate of MRD negativity defined as (BM ALL blasts <0.01%) by flow cytometry, Dose Escalation phase: Investigator assessed rate of minimal residual disease (MRD) negativity (defined as bone marrow (BM) ALL blasts < 0.01%) by flow cytometry, Dose Escalation phase: Time to Event Endpoints: Progression free survival (PFS); overall survival (OS) and duration of response (DoR), Dose Escalation phase: Proportion of patients who achieve adequate response and proceed to hematopoietic stem cell transplant (HSCT), Dose Escalation phase: Incidence, nature, and severity of adverse events and SAEs associated with lymphodepletion, associated anti-leukemic activity and corresponding host T-cell recovery and CAR+ T-cell expansion, Dose Escalation phase: Monitoring of anti-CD52 (alemtuzumab) antibodies in serum pre- and post-administration of alemtuzumab, Dose Escalation phase: Quantitation of alemtuzumab levels in serum post administration, Dose Escalation phase: Quantitation of T, B, and NK cells and total lymphocytes in periperal blood post administration, Dose Expansion Phase: Investigator assessed ORR (CR+CRi+CRh) according to the Response criteria for ALL, Dose Expansion Phase:Time to Event Endpoints: Progression free survival (PFS); overall survival (OS) and duration of response (DoR), Dose Expansion phase: Proportion of subjects who achieve adequate response and proceed to hematopoietic stem cell transplant (HSCT) without additional antileukemia therapy, Dose Expansion phase: MRD negative rate measured on BM by ClonoSeq MRD assay at central laboratory, Dose Expansion phase:Incidence, nature and severity of adverse events and serious adverse events (SAEs) during the Dose Expansion phase, Dose Expansion phase: Monitoring of anti-CD52 (alemtuzumab) antibodies in serum pre- and post-administration of alemtuzumab), Dose Expansion phase: Quantitation of alemtuzumab levels in serum post administration, Dose Expansion phase: Quantitation of T, B, and NK cells and total lymphocytes in periperal blood post administration

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