Clinical trial · Interventional
MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study
NCT07371403CI-TRIAL-00120590recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Lymphoblastic Leukemia Not Having Achieved Remission | — | UNRESOLVED | — |
| Acute Lymphoblastic Leukemia Recurrent | — | UNRESOLVED | — |
| Acute Lymphoblastic Leukemia Refractory | — | UNRESOLVED | — |
| Acute Lymphoblastic Leukemia With Failed Remission | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MB-CART19.1 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MB-CART19.1
- interventionNames
- Genetic: MB-CART19.1
Primary outcomes (1)
- measure
- Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.
- timeFrame
- 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.
- description
- 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.
Secondary outcomes (7)
- measure
- Overall response rate (ORR) (CR, CR with incomplete hematologic recovery (CRh)) on day 28.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.