This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.
Patients must be aged ≥ 18 years and ≤80 years with relapsed or refractory B-cell malignancy.
Absolute CD3 count ≥50 mm^3.
A history of CNS involvement OR
A clinical suspicion at the time of enrollment.
Positive beta human chorionic gonadotropin (hCG) test in female of child-bearing potential.
Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as >20 mg of prednisone or equivalent daily.
Presence of Grade ≥3 non-hematologic toxicities per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 unless believed to be due to underlying disease.
Medical College of Wisconsin
Lead sponsor