This is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. In total approximately 48 patients will be included in the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
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:
* Male or female patients must have r/r CD19-expressing ALL or NHL/CLL
* CD19 expression must be detected on the malignant cells by flow cytometry (leukemia, malignant effusion in NHL) or immunohistochemistry (NHL);
* Age ≥ 1 year (if deemed fit by treating investigator);
* Absolute CD3+ T cell count ≥100/μl;
* ECOG performance score of 0-2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening;
* No active Hepatitis B, Hepatitis C, HIV1/2;
* No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential;
* Signed and dated informed consent/assent by patients
* and meet the following disease-specific criteria:
ALL:
* patients with \>5% blasts in BM (M2 or M3) after at least one standard chemotherapy and one salvage regimen who are ineligible for allogeneic stem cell transplant (alloSCT) or have refractory disease activity precluding alloSCT at this time, or
* patients who have relapsed post alloSCT at least 100 days posttransplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
* patients with Ph+ ALL if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have r/r disease after treatment with at least 2 different TKIs.
* ALL patients with combined bone marrow and CNS and/or testicular relapse are eligible only if the extramedullary disease has been successfully clea…
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.
1Since this is a Phase 1 trial focused on finding the right dose of MB-CART19.1 rather than proving it works, what does that mean for what we actually know so far about its safety and effectiveness for my specific type of B-cell cancer?
2This trial is listed as 'active but not recruiting,' which means they aren't taking new patients — so is there any way to access MB-CART19.1 through a compassionate use program, a related study, or another CAR-T cell therapy trial that might still be enrolling?
3How does MB-CART19.1 compare to the CAR-T cell therapies that are already FDA-approved for my diagnosis, and would it make more sense to try one of those approved options first before considering an experimental approach?
4Because CAR-T therapies can cause serious side effects like cytokine release syndrome, and this trial is still in the dose-finding stage where those risks may not be fully understood yet, how would our team monitor me and manage those risks if I were ever to participate in something like this?
5Given that this trial covers several different conditions — including ALL, B-cell lymphoma, and CLL — does the data gathered so far suggest anything specific about how patients with my exact diagnosis have responded, and is my situation similar enough to those patients to make this relevant to my care?
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
Determination of the recommended dose of MB-CART19.1
Timeframe: until day 28 after infusion of MB-CART19.1