MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia

Sponsor
King Hussein Cancer Center
Study ID
NCT07371403
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia Not Having Achieved Remission
  • Acute Lymphoblastic Leukemia Recurrent
  • Acute Lymphoblastic Leukemia Refractory
  • Acute Lymphoblastic Leukemia With Failed Remission

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • MB-CART19.1 — GENETIC
    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.

Study Details

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.

Key Dates

First listed
Jan 27, 2026
Start date
Feb 28, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MB-CART19.1

Primary Outcome Measure

Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria. [ 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. ]

Central Contacts

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