Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
All participants will undergo leukapheresis for collection of autologous T cells, which will then be manufactured into MB-CART19.1 on-site using CliniMACS Prodigy platform. Successfully manufactured MB-CART19.1 products will be infused back to the patient following a lymphodepleting chemotherapy regimen.
King Hussein Cancer Center
Amman, Jordan
Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.
Assessment of the feasibility and success rate of on-site manufacturing of MB-CART19.1, defined as the proportion of enrolled patients whose cell product is produced and meets established release specifications.
Time frame: From patient enrollment through completion of manufacturing and release testing; estimated 2-4 weeks per patient and up to 12 months for the full cohort.
Overall response rate (ORR) (CR, CR with incomplete hematologic recovery (CRh)) on day 28.
Evaluation of overall response rate (ORR) at Day 28, measured as the percentage of patients who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRh) following MB-CART19.1 infusion.
Time frame: Up to approximately 28 days after the last patient infusion.
Duration of response time from first documented response to progression or death up to 12 months post-infusion
Duration of response time from first documented response to progression or death up to 12 months post-infusion
Time frame: Up to 12 months post-infusion
Rate of measurable residual disease (MRD) negativity at 1-, 3-, 6- and 12-month intervals
Evaluation of rate of measurable residual disease (MRD) negativity at scheduled follow-up visits to monitor clinical status and response post-infusion.
Time frame: at 1-, 3-, 6- and 12-month intervals
MB-CART19.1 manufacturing turnaround time
Time required to complete on-site manufacturing of MB-CART19.1 from leukapheresis to product release.
Time frame: From leukapheresis to product release (estimated 2 weeks per patient).
Overall incidence and severity of adverse events
Assessment of the overall incidence and severity of adverse events (AEs) in patients receiving MB-CART19.1, including all treatment-related and non-treatment-related events, graded according to standard toxicity criteria.
Time frame: From infusion through 12 months post-infusion per patient.
Overall incidence and severity of MB-CART19.1- specific adverse events (cytokine release syndrome (CRS))
Assessment of the overall incidence and severity of cytokine release syndrome (CRS) in patients receiving MB-CART19.1, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Time frame: From infusion through 12 months post-infusion per patient.
Overall incidence and severity MB-CART19.1-specific adverse events (Immune effector cell associated neurotoxicity syndrome (ICANS))
Assessment of the overall incidence and severity of Immune effector cell associated neurotoxicity syndrome (ICANS) in patients receiving MB-CART19.1, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Time frame: From infusion through 12 months post-infusion per patient.
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