CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL (NCT04049383) | Clinical Trial Compass
TerminatedPhase 1
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL
Stopped: Low accrual
United States5 participantsStarted 2020-10-16
Plain-language summary
This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.
Who can participate
Age range1 Year – 70 Years
SexALL
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Inclusion criteria
✓. Diagnosis of B-cell ALL: During the safety phase patients enrolled will be age ≥ 18 to age ≤ 70. Once those three patients have passed the 28-day waiting period post infusion, clearance from the FDA will be obtained to enroll pediatric patients. After FDA clearance -Patients must be aged ≥ 1 year and ≤ 70 years. All patients will have relapsed, refractory disease and no available curative options that meet clinical criteria to initiate treatment.
✓. Relapsed or refractory B cell ALL defined as one of the following:
✓. Primary refractory disease.
✓. Relapsed or refractory disease after two or more lines of systemic therapy.
✓. Relapsed or refractory disease after allogeneic transplant provided subject is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least four weeks prior to enrollment.
✓. Measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, or cytogenetics, or morphological disease in the bone marrow.
✓. Subjects with B-cell ALL must have either CD19 or CD20 positive disease on their most recent bone marrow performed. A minimum of 5% CD19 or CD20 positivity on prior biopsy or bone marrow aspiration (BMA) is required.
✓. Subjects with Ph+ ALL are eligible if they have relapsed or refractory disease and have failed at least two tyrosine kinase inhibitors.
Exclusion criteria
✕. Positive beta-human chorionic gonadotropin (HCG) in female of childbearing potential.
What they're measuring
1
Number of Adverse Events after CAR 20/19-T Cell Infusion.
✕. Subjects with known systemic allergy to bovine or murine products.
✕. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
✕. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy defined as \>20 mg of prednisone.
✕. Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5 from any previous treatment unless it is felt to be due to underlying disease.
✕. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution.
✕. Refusal to participate in the long-term follow-up protocol.