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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)

Name: 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) — clinical trial record (NCT03666000)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 1

SponsorImugene Limited

Started2019-03-11

View on ClinicalTrials.gov ↗

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.

Amendment history 3 changes detected by DataLookout

2026-09-09

Trial arms changed: 6 → 7

2026-09-09

Trial sites reduced: 23 → 15 locations

2026-09-09

Interventions modified

Trial Details

NCT Number	NCT03666000
Lead Sponsor	Imugene Limited
Conditions	Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment	135 participants
Start Date	2019-03-11
Primary Completion	2027-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-09-08