Dose-escalation, Dose-expansion Study of Safety of 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 Phase II	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 1/2a, nonrandomized, open-label, parallel assignment, dose-escalation,
and dose-optimization study to evaluate the safety and clinical activity of PBCAR0191 in
adults with r/r B ALL (Cohort A) and in adults with r/r B-cell NHL (Cohort N) and
identify a treatment regimen most likely to result in clinical efficacy while maintaining
a favorable safety profile.

Objectives

This is a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation,
and dose-optimization study to evaluate the safety and tolerability, find an appropriate
dose to optimize safety and efficacy, and evaluate clinical activity of PBCAR0191 in
subjects with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and
non-Hodgkin lymphoma (NHL). Before initiating PBCAR0191, subjects will be administered
lymphodepletion chemotherapy composed of fludarabine and cyclophosphamide. At Day 0 of
the Treatment Period, subjects will receive an intravenous (IV) infusion of PBCAR0191.
All subjects are monitored during the treatment period through Day 28. All subjects who
receive a dose of PBCAR0191 will be followed in a separate long-term follow-up (LTFU)
study for up to15 years after exiting this study.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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