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Clinical Trial 19829

Cancer Type: Malignant Hematology
Interventions:PBCAR0191 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Bijal Shah

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

Summary

Objective

Primary: To evaluate the safety and tolerability of PBCAR0191 in subjects with relapsed/refractory (r/r) Bcell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL) and find an appropriate dose to optimize safety and efficacy Secondary: To evaluate the clinical activity of PBCAR0191 in subjects with r/r B-ALL and NHL

Inclusion Criteria

  • Participants 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function
  • Criteria for B-ALL:
  • Relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia (B-ALL)
  • Philadelphia chromosome positive (Ph+) disease can be eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy or if they have relapsed/refractory disease
  • Criteria for NHL:
  • r/r CD19+ B-cell NHL that is histologically confirmed by archived tumor biopsy tissue from last relapse and corresponding pathology report
  • Received at least 2 prior chemotherapy-containing regimens consistent with standard of care treatment guidance (e.g. NCCN) subjects with SLL must have previously failed at least 2 lines of chemotherapy/immunotherapy that included ibrutinib and idealisib plus rituximab
  • Measurable or detectable disease according to the Lugano Classification

  • Exclusion Criteria

  • Active hepatitis B or C
  • Active GvHD symptoms
  • C-reactive protein (CRP) >15 mg/dL at screening
  • History of concomitant genetic syndrome known bone marrow failure syndrome
  • Presence of pleural/peritoneal/pericardial catheter
  • Received stem cell transplant within 90 days before screening
  • Received blinatumomab or inotuzumab ozogamicin within 30 days of screening
  • Received systemic immunostimulatory agent within 30 days or 5 half-lives
  • Radioimmunotherapy within 6 months before screening that may interfere with the activity of agents in the study
  • Received an anti-PD-1 or anti-PD-L1 antibodies, or other immune modifying therapy
  • Criteria for B-ALL:
  • Burkitt cell (L3 ALL) or mixed-lineage acute leukemia
  • Evidence of CNS leukemia
  • Criteria for NHL:
  • Active hemolytic anemia
  • Additional criteria apply