Point-of-care MB-CART19.1 CAR-T therapy for relapsed or refractory B‑ALL
MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study
This will test whether autologous, point-of-care manufactured CD19-directed CAR-T cells (MB-CART19.1) can treat children and adults with relapsed or refractory B‑cell acute lymphoblastic leukemia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | King Hussein Cancer Center Academic / other |
| Drugs / interventions | rituximab, blinatumomab, chemotherapy, Fludarabine, CAR-T |
| Locations | 1 site (Amman) |
| Trial ID | NCT07371403 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adults (age ≥1 year) with relapsed or refractory B‑cell ALL who have CD19 expression ≥20%, >5% marrow blasts after prior therapies, adequate performance status, and life expectancy over 12 weeks.
Not a fit: Patients with CD19-negative disease, very rapidly progressive leukemia that precludes the time needed for manufacturing, active graft-versus-host disease, recent immunosuppression, or insufficient organ function are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could shorten waiting times for personalized CAR-T therapy and potentially induce remissions in patients with relapsed or refractory B-ALL.
How similar studies have performed: CD19-directed CAR-T therapies have produced high remission rates in relapsed/refractory B-ALL in prior studies, while point-of-care manufacturing is an emerging approach with limited but promising feasibility data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \>5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen. 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 this trial is running
Amman
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.