RECRUITINGINTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form/assent.
- CNS and/or testicular involvement are allowed, only if cleared and in the presence of systemic involvement.
Who Should NOT Join This Trial:
- 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 conditions (where your immune system attacks your own body), or history of autoimmune conditions (where your immune system attacks your own body) 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
Locations (1)
King Hussein Cancer Center
Amman, Jordan