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

NCT07271121 | Recruiting Phase 2 DMC

• 1 other identifier: 24 KHCC 192
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients \>18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Patients will receive a fresh single dose of MB-CART-19.1 and will be followed for 12 months and evaluated for efficacy and safety.

Conditions

Non-Hodgkin Lymphoma Refractory/ Relapsed

Keywords

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

Outcome Measures

Primary Outcomes (1)

• overall response rate

  ORR in NHL patients defined as the rate of overall response (CR or PR)

  on week 4 and at month 3 in patients not achieving CR on week 4

Secondary Outcomes (8)

• Safety and toxicity

  From enrolment to the end of follow up at one year

• CRS

  From enrolment to the end of follow up at one year

• Disease-free survival

  at 1 year after receiving study treatment

• Duration of response

  From enrolment to end of follow up at one year

• ICANS

  From enrolment to the end of follow up at one year

Study Arms (1)

MB-CART-19.1

EXPERIMENTAL

One dose of fresh MB-CART-19.1 at dose level 1- 3x10\^6/kg ABW for patients. The leukapheresed product will be used for the individual manufacturing of MB-CART19.1 by using the automated closed CliniMACS Prodigy System

Other: MB-CART-19.1

Interventions

MB-CART-19.1 OTHER

The leukapheresed product will be used for the individual manufacturing of MB-CART19.1 by using the automated closed CliniMACS Prodigy System. CD4+ and CD8+ T-cells will be selected, enriched and activated, followed by lentivirus-based transduction with the CD19 CAR construct. Then the MB-CART19.1 transduced T cells will be expanded and finally formulated.

MB-CART-19.1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients with a diagnosis of aggressive NHL:
• Patients after progression on at least one standard chemotherapy and one salvage regimen or
• Patients considered for alloSCT but are found ineligible or
• 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.
• CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry
• Age \> 18 year up to 75 years old (if deemed fit by treating investigator);
• Baseline absolute CD3+ T cell count by FACS ≥100/µl;
• ECOG performance score of 0-2 at screening;
• No active Hepatitis B, Hepatitis C, HIV I/II
• 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;
• Signed and dated informed consent, before conduct of any trial-specific procedure.

You may not qualify if:

• Residual CNS disease
• Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;
• Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
• History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years;
• Pulmonary function: Patients with pre-existing severe lung disease or DLCO of less than 50% or active pulmonary infiltrates on imaging studies.
• Cardiac function: left ventricular ejection faction \<50% by echocardiogram,
• Renal function: Creatinine clearance \<50 mL/min/1.73 m2, by Cockcroft-Gault formula (Cockcroft and Gault 1976) for patients ≥18 years.
• 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.
• Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy;
• Pregnant or breast-feeding females
• 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;
• 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;
• Concurrent participation in another interventional trial that could interact with this trial, e.g. CAR T trials.
• Other investigational treatment within 4 weeks before CARTs infusion;
• Cerebral dysfunction, legal incapacity of adult patients;

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective single center, open label, non-randomized, single arm, single dose, optimal 2-stage Simon design, and Phase II clinical trial

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 9, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)