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

King Hussein Cancer Center

Status

Not yet enrolling

Conditions

Acute Lymphoblastic Leukemia Refractory

Acute Lymphoblastic Leukemia With Failed Remission

Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Recurrent

Acute Lymphoblastic Leukemia Not Having Achieved Remission

Treatments

Genetic: MB-CART19.1

Study type

Interventional

Funder types

Other

Identifiers

NCT07371403

25KHCC164

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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