Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell (NCT03019055) | Clinical Trial Compass
CompletedPhase 1
Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell
United States26 participantsStarted 2017-10-16
Plain-language summary
This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Diagnosis of B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) / small lymphocytic leukemia (SLL): Patients must be aged≥18 years with relapsed, refractory disease and no available curative options that meet clinical criteria to initiate treatment.
✓. Patients with B-cell NHL or CLL/SLL must have either CD19 or CD20 positive disease on most recent biopsy performed (a repeat biopsy is not mandatory for this study except as noted below). A minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry on prior or repeat biopsy is required.
✓. Absolute CD3+ T cell count ≥50/mm\^3.
✓. MRI brain and Lumbar Puncture with cerebral spinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement only in patients with history of CNS involvement.
✓. Measurable disease must have been documented within 4 weeks of the time of consent defined as the following by disease specific subtype:
✓. B-cell NHL: Active disease defined as nodal lesions greater than 20 mm in the long axis or extranodal lesions \>10 mm in long and short axis or bone marrow involvement that is biopsy proven.
✓. CLL/SLL: Active disease by either bone marrow, peripheral flow cytometry, or CT and/or positron emission tomography (PET) imaging with nodal disease.
✓. Patients should have failed at least two lines of a standard treatment and meet disease specific criteria detailed below:
Exclusion criteria
✕. Positive beta-human chorionic gonadotropin in females of child-bearing potential.
What they're measuring
1
Number of Adverse Events After CAR 20/19-T Cell Infusion
✕. Patients with known systemic allergy to bovine or murine products.
✕. Known prior positive serology for human anti-mouse antibody (HAMA).
✕. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
✕. 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 or equivalent daily.
✕. Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 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. Minimum of ≥4 weeks required from administration of any other investigational agents on other clinical trials prior to enrollment on this CAR-T protocol.
✕. Refusal to participate in the long-term follow-up protocol.