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.
Sequential
1 X 10^6 cells/kg
Biological/VaccineDose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
2.5 X 10^6 cells/kg
Biological/VaccineDose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
Dose expansion: The maximum tolerated dose of CAR-T cells
Biological/VaccineDose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg.
Maximum tolerated dose
The maximum tolerated dose (MTD) is the highest dose of a drug or treatment that does not cause dose-limiting toxicities (DLTs). This trial will utilize a 3+3 design to determine the safe dose. Three patients are enrolled and treated at the starting (lowest) dose level. * 0 DLTs: If none of the three patients experience a DLT, the next cohort of three patients is treated at the next higher dose level. * 1 DLT: If one patient experiences a DLT, an additional three patients are enrolled at the same dose level (expanding the cohort to six patients total). * 2 or more DLTs: If two or more patients in a cohort of three (or two or more in an expanded cohort of six) experience DLTs, the MTD is considered to have been exceeded. The trial stops escalating and the previous dose level is defined as the MTD.
Adverse Events
The number of subjects with adverse events, defined as non-hematologic Grade 3/4 events per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, as well as Grade 3-4 CRS, ICANS, and IEC-HS events per the recent ASTCT consensus criteria, that are possibly, probably, or definitely related to study treatment and do not resolve to ≤ Grade 2 by Day 28 post-infusion.
Overall Response Rate (ORR)
ORR is defined as the number of subjects who achieve a best overall response of complete response (CR) or partial response (PR), as determined by the Lugano (for Non-Hodgkin Lymphoma subjects) or Hallek (for Chronic Lymphocytic Leukemia subjects) criteria, following h20.19 CAR T-cell infusion.
Complete Response (CR) Rate
CR rate is defined as the number of subjects who achieve a CR following h20.19 CAR T-cell infusion.
Duration of Response (DOR)
DOR is defined as the time from the first documented CR or partial response (PR) following h20.19 CAR T-cell infusion to disease progression, as determined by the Lugano or Hallek criteria, or death, whichever occurs first.
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