Point-of-care MB-CART19.1 CAR-T therapy for relapsed or refractory B‑ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, prospective, open-label feasibility study delivers autologous CD19-directed CAR-T cells (MB-CART19.1) manufactured at the point of care for pediatric and adult patients with relapsed or refractory B-ALL. Patients undergo leukapheresis, on-site manufacturing of MB-CART19.1, lymphodepleting chemotherapy, and infusion, with structured follow-up to capture manufacturing success, safety, and early efficacy signals. Eligible participants must have CD19 expression ≥20%, persistent marrow disease (>5% blasts) after prior frontline and salvage therapy, acceptable performance status, and estimated life expectancy >12 weeks; select post-alloSCT patients without active GVHD or recent immunosuppression are allowed. The primary focus is technical and operational feasibility of local manufacturing alongside monitoring of clinical safety and initial response rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 1 year as long as if deemed fit by treating investigator
* CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.
* Patients with relapsed or refractory disease with 0.01% or higher blasts in the bone marrow, or patients with confirmed disease progression as demonstrated by FDG PET-CT or CT/MRI of the affected lymph node or spleen after at least 2 cycles/lines of chemotherapy are eligible for enrollment. For patients with Philadelphia-positive disease, a second-generation or higher TKI must have been utilized in one of the treatment lines.
* Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
* Estimated life expectancy \> 12 weeks
* Karnofsky or Lansky (age dependent) performance score ≥ 60
* Patients and/or parents must give their written informed consent/assent.
* CNS and/or testicular involvement are allowed, only if cleared and in the presence of systemic involvement.

Exclusion Criteria:

* Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator.
* Persistent extramedullary disease.
* Isolated CNS and/or testicular disease.
* Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
* Active hepatitis B, C or HIV
* Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
* History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.
* Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \< 65%) or an oxygen requirement of \>28% O2 FiO2 or active pulmonary infection.
* Cardiac function: Left ventricular ejection fraction \<50% by echocardiography
* Renal function: Creatinine clearance \<50 mL/min/1.73 m2
* Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \> 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.
* Pregnant or breast-feeding females
* Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (\<0.5 mg/kg/day of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte

Where it's running

• King Hussein Cancer Center
  Amman, Jordan Recruiting

Study contacts

• Principal investigator: Dr Zaid Abdel Rahman, Consultant,Hematology/Oncology — King Hussein Cancer Center
• Study coordinator: Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology
• Email: ZA.11040@KHCC.JO
• Phone: +962797101838

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.