Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.

Trial Details

NCT ID
NCT03666000
Phase
PHASE1
Sponsor
Imugene Limited
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Azer-cel
  • Fludarabine
  • Cyclophosphamide
  • IL-2
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Criteria for B-ALL:
  • Participant has confirmed unequivocal r/r CD19+ B-ALL.
  • Criteria for NHL and CLL/SLL:
  • Participant has unequivocal aggressive CD19+ r/r B-cell NHL that is confirmed by tumor biopsy tissue from last relapse after CD19-directed therapy.

For full eligibility, visit ClinicalTrials.gov.

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