Acute Lymphoblastic LeukemiaNCT07371403
MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
A study testing MB-CART19.1 in people with Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia Recurrent, run by King Hussein Cancer Center at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia Refractory
- What is being tested?
- MB-CART19.1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJordan
- Study dates
- 20 Feb 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
King Hussein Cancer Center
Amman, 11941
Zaid Abdel Rahman, MD, 00962796420055, za.11040@khcc.jo
Farah Zahran, MSc Clinical Pharmacy, 00962796420055, fzahran@khcc.jo
About this study
Official title: 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.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia Refractory, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia With Failed Remission
- Being tested
- MB-CART19.1
- Keywords
- CAR-T, MB-CART19.1, ALL, acute lymphoblastic leukemia, relapsed acute lymphoblastic leukemia, refractory acute lymphoblastic leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-CART19.1Genetic
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.
| Study group | Role | What they receive |
|---|---|---|
| MB-CART19.1 | Experimental | Not described Receives: Genetic: MB-CART19.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
Duration of response time from first documented response to progression or death up to 12 months post-infusion
Measured: Up to 12 months post-infusion
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.
Measured: at 1-, 3-, 6- and 12-month intervals
MB-CART19.1 manufacturing turnaround time
Time required to complete on-site manufacturing of MB-CART19.1 from leukapheresis to product release.
Measured: From leukapheresis to product release (estimated 2 weeks per patient).
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.
Measured: From infusion through 12 months post-infusion per patient.
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.
Measured: 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))
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.
Measured: From infusion through 12 months post-infusion per patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start20 Feb 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaid Abdel Rahman, MD, King Hussein Cancer Center
- Investigators
- Dr Zaid Abdel Rahman, Consultant,Hematology/Oncology, Principal investigator, King Hussein Cancer CenterDr. Hasan Hashem, Consultant,Hematology/Oncology, Principal investigator, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371403
- Sponsor's protocol ID
- 25KHCC164
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07371403
- Acronym / sponsor ID
- 25KHCC164
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MB-CART19.1 | Experimental | Genetic: MB-CART19.1 |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-CART19.1All 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. | Genetic | MB-CART19.1 |
Primary outcome
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.
7 secondary outcomes
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.
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
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
MB-CART19.1 manufacturing turnaround time
Time frame: 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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MB-CART19.1 in people with Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia Recurrent, run by King Hussein Cancer Center at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology (+962797101838, ZA.11040@KHCC.JO), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.