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

NCT07371403 | Recruiting DMC

• 1 other identifier: 25KHCC164
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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.

  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 (7)

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

  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

  Up to 12 months post-infusion

• Rate of measurable residual disease (MRD) negativity at 1-, 3-, 6- and 12-month intervals

  at 1-, 3-, 6- and 12-month intervals

• MB-CART19.1 manufacturing turnaround time

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

• Overall incidence and severity of adverse events

  From infusion through 12 months post-infusion per patient.

Study Arms (1)

MB-CART19.1

EXPERIMENTAL

Genetic: MB-CART19.1

Interventions

MB-CART19.1 GENETIC

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.

MB-CART19.1

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dr Zaid Abdel Rahman, Consultant,Hematology/Oncology

  King Hussein Cancer Center

  PRINCIPAL INVESTIGATOR

• Dr. Hasan Hashem, Consultant,Hematology/Oncology

  King Hussein Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology

CONTACT

+962797101838; ZA.11040@KHCC.JO

Dr. Hasan Hashem, Consultant,Hematology/Oncology

CONTACT

00962797207439; hh.08847@khcc.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Hematology, Stem Cell Transplantation and Cellular Therapies

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

JO (1)