MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia

March 24, 2026 updated by: Zaid Abdel Rahman, MD, King Hussein Cancer Center

MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study

Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology
  • Phone Number: +962797101838
  • Email: ZA.11040@KHCC.JO

Study Contact Backup

  • Name: Dr. Hasan Hashem, Consultant,Hematology/Oncology
  • Phone Number: 00962797207439
  • Email: hh.08847@khcc.jo

Study Locations

  • Jordan
      • Amman, Jordan, 11941
        • Recruiting
        • King Hussein Cancer Center
        • Contact:
          • Farah Zahran, MSc Clinical Pharmacy
          • Phone Number: 00962796420055
          • Email: fzahran@khcc.jo
        • Contact:
        • Principal Investigator:
          • Zaid Abdel Rahman, Consultant,Hematology/Oncology
        • Principal Investigator:
          • Hasan Hashem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 1 year as long as if deemed fit by treating investigator
  • CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.
  • Patients with relapsed or refractory disease with >5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen. For patients with Philadelphia-positive disease, a second generation or higher TKI must have been utilized in one of the treatment lines.
  • Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
  • Estimated life expectancy > 12 weeks
  • Karnofsky or Lansky (age dependent) performance score ≥ 60
  • Patients and/or parents must give their written informed consent/assent.
  • CNS and/or testicular involvement are allowed, only if cleared and in the presence of systemic involvement.

Exclusion Criteria:

  • Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator.
  • Persistent extramedullary disease.
  • Isolated CNS and/or testicular disease.
  • Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
  • Active hepatitis B, C or HIV
  • Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
  • History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.
  • Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC < 65%) or an oxygen requirement of >28% O2 FiO2 or active pulmonary infection.
  • Cardiac function: Left ventricular ejection fraction <50% by echocardiography
  • Renal function: Creatinine clearance <50 mL/min/1.73 m2
  • Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT > 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.
  • Pregnant or breast-feeding females
  • Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (<0.5 mg/kg/day of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MB-CART19.1
Genetic: MB-CART19.1
All participants will undergo leukapheresis for collection of autologous T cells, which will then be manufactured into MB-CART19.1 on-site using CliniMACS Prodigy platform. Successfully manufactured MB-CART19.1 products will be infused back to the patient following a lymphodepleting chemotherapy regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.
Time Frame: From patient enrollment through completion of manufacturing and release testing; estimated 2-4 weeks per patient and up to 12 months for the full cohort.
Assessment of the feasibility and success rate of on-site manufacturing of MB-CART19.1, defined as the proportion of enrolled patients whose cell product is produced and meets established release specifications.
From patient enrollment through completion of manufacturing and release testing; estimated 2-4 weeks per patient and up to 12 months for the full cohort.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) (CR, CR with incomplete hematologic recovery (CRh)) on day 28.
Time Frame: Up to approximately 28 days after the last patient infusion.
Evaluation of overall response rate (ORR) at Day 28, measured as the percentage of patients who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRh) following MB-CART19.1 infusion.
Up to approximately 28 days after the last patient infusion.
Duration of response time from first documented response to progression or death up to 12 months post-infusion
Time Frame: Up to 12 months post-infusion
Duration of response time from first documented response to progression or death up to 12 months post-infusion
Up to 12 months post-infusion
Rate of measurable residual disease (MRD) negativity at 1-, 3-, 6- and 12-month intervals
Time Frame: at 1-, 3-, 6- and 12-month intervals
Evaluation of rate of measurable residual disease (MRD) negativity at scheduled follow-up visits to monitor clinical status and response post-infusion.
at 1-, 3-, 6- and 12-month intervals
MB-CART19.1 manufacturing turnaround time
Time Frame: From leukapheresis to product release (estimated 2 weeks per patient).
Time required to complete on-site manufacturing of MB-CART19.1 from leukapheresis to product release.
From leukapheresis to product release (estimated 2 weeks per patient).
Overall incidence and severity of adverse events
Time Frame: From infusion through 12 months post-infusion per patient.
Assessment of the overall incidence and severity of adverse events (AEs) in patients receiving MB-CART19.1, including all treatment-related and non-treatment-related events, graded according to standard toxicity criteria.
From infusion through 12 months post-infusion per patient.
Overall incidence and severity of MB-CART19.1- specific adverse events (cytokine release syndrome (CRS))
Time Frame: From infusion through 12 months post-infusion per patient.
Assessment of the overall incidence and severity of cytokine release syndrome (CRS) in patients receiving MB-CART19.1, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
From infusion through 12 months post-infusion per patient.
Overall incidence and severity MB-CART19.1-specific adverse events (Immune effector cell associated neurotoxicity syndrome (ICANS))
Time Frame: From infusion through 12 months post-infusion per patient.
Assessment of the overall incidence and severity of Immune effector cell associated neurotoxicity syndrome (ICANS) in patients receiving MB-CART19.1, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
From infusion through 12 months post-infusion per patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Hussein Cancer Center

Investigators

  • Principal Investigator: Dr Zaid Abdel Rahman, Consultant,Hematology/Oncology, King Hussein Cancer Center
  • Principal Investigator: Dr. Hasan Hashem, Consultant,Hematology/Oncology, King Hussein Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25KHCC164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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