Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants
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.
| Condition(s) | Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Key Inclusion 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 Phase 1 Dose Escalation: * Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation * Follicular lymphoma (FL) including Grade 3 or transformed FL * High-grade B-cell lymphoma (HGBCL) * Primary mediastinal lymphoma For Phase 1b Dose Expansion (CAR T-relapsed cohort): * DLBCL not otherwise specified (NOS) * HGBCL * DLBCL transformed from the following indolent lymphoma subtypes (FL, Marginal Zone lymphoma \[MZL\], and Waldenstrom's Macroglobulinemia \[WM\]) * Other large B-cell lymphoma (LBCL) su |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Imugene Limited |
| Locations | Gilbert, Arizona, United States; Duarte, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States (+17 more sites) |
| Start date | 2019-03-11 |
| NCT ID | NCT03666000 |
| Official listing | https://clinicaltrials.gov/study/NCT03666000 |