๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-28

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) (NCT03666000)

A Phase 1/1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 (Azercabtagene Zapreleucel or "Azer-cel") in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Imugene Limited

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: Banner MD Anderson Cancer Center โ€” Gilbert, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (23 Sites)

  • Banner MD Anderson Cancer Center โ€” Gilbert, Arizona
  • City of Hope โ€” Duarte, California
  • H. Lee Moffitt Cancer Center โ€” Tampa, Florida
  • Winship Cancer Institute Emory University โ€” Atlanta, Georgia
  • Northside Hospital Cancer Institute โ€” Atlanta, Georgia
  • University of Maryland โ€” Baltimore, Maryland
  • Tufts Medical Center โ€” Boston, Massachusetts
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • Barbara Ann Karmanos Cancer Institute (Wayne State University) โ€” Detroit, Michigan
  • University of Minnesota โ€” Minneapolis, Minnesota
  • Weill Cornell Medical College - NY Presbyterian Hospital โ€” New York, New York
  • Columbia University Irving Medical Center/New York Presbyterian Hospital โ€” New York, New York
  • Duke University โ€” Durham, North Carolina
  • Ohio State University โ€” Columbus, Ohio
  • Lifespan Cancer Institute at Rhode Island Hospital โ€” Providence, Rhode Island
  • Baylor University Medical Center โ€” Dallas, Texas
  • MD Anderson โ€” Houston, Texas
  • Medical College of Wisconsin โ€” Milwaukee, Wisconsin
  • Royal Prince Alfred Hospital โ€” Camperdown, New South Wales
  • Liverpool Hospital โ€” Liverpool, New South Wales
  • Royal Adelaide Hospital โ€” Adelaide, South Australia
  • St Vincent's Hospital Melbourne โ€” Fitzroy, Victoria
  • Barwon Health - Andrew Love Cancer Centre โ€” Geelong, Victoria

๐Ÿ“ž Contact the Study Coordinator

Phone: (984) 245-0082

Email: info@imugene.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—