Hospital-Made cancer fighters: new CAR-T trial for leukemia
NCT ID NCT07371403
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study is testing whether a personalized cell therapy called MB-CART19.1 can be manufactured right at the hospital for children and adults with B-cell acute lymphoblastic leukemia that has come back or not responded to standard treatments. The therapy uses the patient's own immune cells, which are collected, modified to target cancer cells, and then infused back. The main goal is to see if the cells can be made successfully on-site, with a secondary look at how well they work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MB-CART19.1 (a type of CAR-T cell therapy made from the patient's own immune cells)
- What this could lead to
- If successful, this could show that making CAR-T cells at the hospital is possible, potentially offering a faster and more accessible treatment for patients with relapsed or refractory B-ALL.
- What could go wrong
- This is a very small, early feasibility study with only 12 participants. It focuses on whether the cells can be made, not yet on how well they work. The therapy may not be effective or could cause serious side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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King Hussein Cancer Center
RECRUITINGAmman, 11941, Jordan
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