MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
Jordan12 participantsStarted 2026-02-20
Plain-language summary
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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial's main goal seems to be testing whether MB-CART19.1 can be successfully manufactured on-site rather than directly measuring whether it puts my leukemia into remission — does that mean it's more focused on production feasibility than on my treatment outcome, and how does that affect what I might personally gain from enrolling?
2Since this trial is listed as Phase NA, what does that tell us about how much safety and effectiveness data already exists for MB-CART19.1, and are there other CAR-T therapies with more established track records that might be worth comparing it to for my situation?
3If the manufacturing process fails or the product doesn't meet release criteria for my specific cells, what would my treatment options be at that point, and how might the time spent attempting manufacturing affect my disease?
4Given that my leukemia is relapsed or refractory, how does this trial fit alongside other available salvage therapies or approved CAR-T products, and is there a reason you'd recommend this study over a more established treatment path?
5What does 'on-site manufacturing' mean for me practically — where would it happen, how long would I need to be near that facility, and how does that logistical burden compare to other treatment options you'd consider for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.
Timeframe: 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.
Trial details
NCT IDNCT07371403
SponsorKing Hussein Cancer Center
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2029-01
Contact for this trial
Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology