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Engineered immune cells take on tough lymphoma in new trial

NCT ID NCT07271121

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • King Hussein Cancer Center

    RECRUITING

    Amman, 11941, Jordan

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