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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Hodgkin Lymphoma Refractory/ Relapsed
• Intervention / Treatment: Other: MB-CART-19.1

Detailed Description

This is a prospective single center, open label, non-randomized, single arm, single dose, optimal 2-stage Simon design, and Phase II clinical trial. The trial includes Adult patients > 18-year-old and up to 75 years old, with CD19+ non-Hodgkin lymphoma including diffuse Large B-cell Lymphoma, primary mediastinal B-cell lymphoma and relapsed refractory follicular lymphoma.

Single infusion of freshly prepared MB-CART19.1 cells manufactured according to Miltinyi Biotec product manufacturing guidelines and good manufacturing product (GMP) of KHCC manufacturing standard operating procedures (SOPs).

The patients will receive one infusion of the MB-CART19.1 product in infusion solution at a final volume adapted to the patients' weight, over a time of approx. 5-20 minutes (intravenous infusion via a large peripheral vein or central line).

The objective of this trial is to assess the efficacy and safety of ex vivo generated MB-CART19.1 in adult patients with relapsed or refractory CD19 positive Non-Hodgkin lymphoma including diffuse Large B-cell Lymphoma, primary mediastinal B-cell lymphoma and relapsed refractory follicular lymphoma

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11941
    • Recruiting
    • King Hussein Cancer Center
    • Contact: Dr. Khalid Halahleh, MD; Phone Number: 00962778484088; Email: kh.06314@khcc.jo
    • Contact: Farah Zahran, MSc Clinical Pharmacy; Phone Number: 00962796420055; Email: fzahran@khcc.jo
    • Principal Investigator: Dr. Khalid Halahleh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MB-CART-19.1; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and toxicity	Safety and toxicity of MB-CART19.1, Overall incidence and severity of adverse events	From enrolment to the end of follow up at one year
CRS	The incidence rate of CRS	From enrolment to the end of follow up at one year
Disease-free survival	Disease-free at 1 year after MB-CART 19.1 in patients not receiving alloHCT	at 1 year after receiving study treatment
Duration of response	Duration of response	From enrolment to end of follow up at one year
ICANS	The incidence rate of ICANS	From enrolment to the end of follow up at one year
relapse rate	relapse rate	From enrolment to the end of follow up at one year
time to relapse	time to relapse	From enrolment to the end of follow up at one year
overall survival	overall survival at 1 year after MB-CART 19.1 in patients not receiving alloHCT	at 1 year after receiving study treatment

Collaborators and Investigators

• Sponsor: King Hussein Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Non-Hodgkin Lymphoma Refractory/ Relapsed; MB-CART-19.1
• Other Study ID Numbers: 24 KHCC 192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: to maintain privacy and confidentiality of personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No