Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients With r/r NHL and r/r B-cell ALL

Active:	Yes
Cancer Type:	Cancer-Related Syndrome	NCT ID:	NCT03666000
Trial Phases:	Phase I	Protocol IDs:	PBCAR0191-01 (primary) NCI-2019-01892
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Imugene Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT03666000

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 and r/r B-cell NHL.

Objectives

This is a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation,
and dose-expansion study to evaluate the safety and tolerability, find an appropriate
dose to optimize safety and efficacy, and evaluate clinical activity of azer-cel in
participants with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL)
and non-Hodgkin lymphoma (NHL). Before initiating azer-cel, participants will be
administered lymphodepletion (LD). At Day 0 of the Treatment Period, participants will
receive an intravenous (IV) infusion of azer-cel. All participants will be monitored
through D720 or progression. All participants who receive a dose of azer-cel will be
followed in a separate long-term follow-up (LTFU) study for up to 15 years after exiting
this study.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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