Engineered immune cells take on tough lymphoma in new trial
NCT ID NCT07271121
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing a personalized cell therapy called MB-CART19.1 in 26 adults with CD19-positive non-Hodgkin lymphoma that has relapsed or not responded to prior treatments. The therapy uses a patient's own immune cells, which are modified in the lab to recognize and attack cancer cells. Participants receive a single dose and are monitored for one year to see how well it works and what side effects occur.
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 offer a new treatment option for patients with hard-to-treat non-Hodgkin lymphoma that has come back or not responded to standard therapies.
- What could go wrong
- This is a small, single-center phase II trial, so results may not apply broadly. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jun 2028
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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18 to 75 years
- 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: 1. Eligible patients with a diagnosis of aggressive NHL: 1. Patients after progression on at least one standard chemotherapy and one salvage regimen or 2. Patients considered for alloSCT but are found ineligible or 3. Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment. 2. Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion. 3. CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry 4. Age \> 18 year up to 75 years old (if deemed fit by treating investigator); 5. Baseline absolute CD3+ T cell count by FACS ≥100/µl; 6. ECOG performance score of 0-2 at screening; 7. No active Hepatitis B, Hepatitis C, HIV I/II 8. No childbearing potential or negative pregnancy test at screening within 7 days from starting lymphodepletion chemotherapy and before bridging chemotherapy in women with childbearing potential; 9. Signed and dated informed consent, before conduct of any trial-specific procedure. Exclusion Criteria: 1. Residual CNS disease 2. Current autoimmune disease, or history of autoimmune disease with potential CNS involvement; 3. Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis) 4. History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years; 5. Pulmonary function: Patients with pre-existing severe lung disease or DLCO of less than 50% or active pulmonary infiltrates on imaging studies. 6. Cardiac function: left ventricular ejection faction \<50% by echocardiogram, 7. Renal function: Creatinine clearance \<50 mL/min/1.73 m2, by Cockcroft-Gault formula (Cockcroft and Gault 1976) for patients ≥18 years. 8. Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \> 5 times upper limit of normal, unless due to lymphoma liver infiltration in the estimation of the investigator. 9. Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy; 10. Pregnant or breast-feeding females 11. Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, Fludarabine/clofarabine or immunosuppressive (Calcineurin inhibitors) drugs and antibodies or investigational drugs or donor lymphocyte transfusions or radiation therapy within 30 days prior to apheresis, and rituximab within 2 weeks with the exception of Intrathecal chemotherapy is allowed prior to treatment, but should be discontinued 10 days prior to-CART19 infusion to limit the risk of neurotoxicities; 12. Patients of child-bearing or fathering potential not willing to practice an effective form of birth control from the time of enrollment and for three months after dosing of the CARTs; 13. Concurrent participation in another interventional trial that could interact with this trial, e.g. CAR T trials. 14. Other investigational treatment within 4 weeks before CARTs infusion; 15. Cerebral dysfunction, legal incapacity of adult patients; 16. Committal to an institution on judicial or official order.
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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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- Can an antibody drug boost standard chemotherapy against an aggressive blood cancer?
- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?