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RecruitingNCT07371403Updated Aug 5, 2026

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

An interventional study of MB-CART19.1 in Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia Recurrent and Acute Lymphoblastic Leukemia Refractory, sponsored by King Hussein Cancer Center. Recruiting at 1 site in Jordan. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by King Hussein Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
1 Year and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia Recurrent
  • Acute Lymphoblastic Leukemia Refractory
  • Acute Lymphoblastic Leukemia Not Having Achieved Remission
  • Acute Lymphoblastic Leukemia With Failed Remission

Keywords

  • CAR-T
  • MB-CART19.1
  • ALL
  • acute lymphoblastic leukemia
  • relapsed acute lymphoblastic leukemia
  • refractory acute lymphoblastic leukemia
03

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

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 0.01% or higher blasts in the bone marrow, or patients with confirmed disease progression as demonstrated by FDG PET-CT or CT/MRI of the affected lymph node or spleen after at least 2 cycles/lines of chemotherapy are eligible for enrollment. 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    MB-CART19.1

    Genetic: MB-CART19.1

Interventions

  • GeneticMB-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.

05

What researchers measure

Primary outcomes

  1. Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.

    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.

    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.

Secondary outcomes

  1. Overall response rate (ORR) (CR, CR with incomplete hematologic recovery (CRh)) on day 28.

    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.

    Time frame: Up to approximately 28 days after the last patient infusion.

  2. Duration of response time from first documented response to progression or death up to 12 months post-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

  3. Rate of measurable residual disease (MRD) negativity 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.

    Time frame: at 1-, 3-, 6- and 12-month intervals

  4. MB-CART19.1 manufacturing turnaround time

    Time required to complete on-site manufacturing of MB-CART19.1 from leukapheresis to product release.

    Time frame: From leukapheresis to product release (estimated 2 weeks per patient).

  5. Overall incidence and severity of adverse events

    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.

    Time frame: From infusion through 12 months post-infusion per patient.

  6. Overall incidence and severity of MB-CART19.1- specific adverse events (cytokine release syndrome (CRS))

    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.

    Time frame: From infusion through 12 months post-infusion per patient.

  7. Overall incidence and severity MB-CART19.1-specific adverse events (Immune effector cell associated neurotoxicity syndrome (ICANS))

    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.

    Time frame: From infusion through 12 months post-infusion per patient.

06

Study locations

1 of 1 sites recruiting
  • King Hussein Cancer Center
    Amman, 11941, Jordan
    • Zaid Abdel Rahman, MD · Contact · za.11040@khcc.jo · 00962796420055
    • Farah Zahran, MSc Clinical Pharmacy · Contact · fzahran@khcc.jo · 00962796420055
    • Zaid Abdel Rahman, Consultant,Hematology/Oncology · Principal investigator
    • Hasan Hashem, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07371403
Lead sponsor
King Hussein Cancer Center
Responsible party
Zaid Abdel Rahman, MD (Consultant Hematology, Stem Cell Transplantation and Cellular Therapies, King Hussein Cancer Center) — Principal investigator
First posted
Jan 27, 2026
Start date
Feb 20, 2026
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Aug 5, 2026

Study contacts

Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology
Contact
ZA.11040@KHCC.JO
+962797101838
Dr. Hasan Hashem, Consultant,Hematology/Oncology
Contact
hh.08847@khcc.jo
00962797207439
Dr Zaid Abdel Rahman, Consultant,Hematology/Oncology
principal investigator · King Hussein Cancer Center
Dr. Hasan Hashem, Consultant,Hematology/Oncology
principal investigator · King Hussein Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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