MB-CART19.1 CAR-T for adults with relapsed or refractory CD19-positive non-Hodgkin lymphoma.

A Phase II Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL

This study will try a single infusion of MB-CART19.1 CAR-T cells in adults with relapsed or refractory CD19-positive non-Hodgkin lymphoma to see if it can reduce disease and is safe.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: King Hussein Cancer Center (Academic / other)
• Drugs / interventions: rituximab, CAR T, chemotherapy, radiation, Fludarabine, CART
• Locations: 1 site (Amman)
• Trial ID: NCT07271121 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, open-label, non-randomized, single-arm Phase II trial using an optimal two-stage Simon design to test a single fresh infusion of MB-CART19.1. Eligible adults (ages >18 up to 75) have CD19-positive non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and relapsed refractory follicular lymphoma. Patients receive one intravenously infused dose of GMP-manufactured MB-CART19.1 and are followed for 12 months for safety and activity. The trial is conducted at King Hussein Cancer Center in Amman with standardized manufacturing and monitoring procedures.

Who should consider this trial

Good fit: Adults 18–75 years old with CD19-positive relapsed or refractory aggressive NHL (e.g., DLBCL, primary mediastinal B-cell lymphoma, relapsed refractory follicular lymphoma) who have progressed after standard chemotherapy and at least one salvage regimen or are ineligible for alloSCT or relapsed ≥100 days post-alloSCT, with ECOG 0–2, baseline CD3+ ≥100/µL, and no active hepatitis B/C or HIV.

Not a fit: Patients without CD19 expression on their tumor, with active uncontrolled infections, active graft-versus-host disease or ongoing immunosuppression, very low T‑cell counts, or who are pregnant are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the treatment could produce meaningful tumor responses or durable remissions for patients with relapsed or refractory CD19-positive non-Hodgkin lymphoma who have limited options.

How similar studies have performed: Other CD19-directed CAR-T therapies have produced significant responses and durable remissions in relapsed/refractory B‑cell lymphomas, although outcomes vary by product and patient population.

Eligibility criteria

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.

Where this trial is running

Amman

• King Hussein Cancer Center — Amman, Jordan (Recruiting)

Conditions Non-Hodgkin Lymphoma Refractory/ Relapsed; MB-CART-19.1