ClinicalTrials.gov record
Recruiting Phase 1 Interventional

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)

ClinicalTrials.gov ID: NCT03666000

Public ClinicalTrials.gov record NCT03666000. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 5, 2026, 7:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT03666000
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Imugene Limited
Industry
Enrollment
135 participants

Conditions and interventions

Interventions

  • Azer-cel Biological
  • Cyclophosphamide Drug
  • Fludarabine Drug
  • IL-2 Drug

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 10, 2019
Primary completion
May 31, 2027
Completion
May 31, 2027
Last update posted
Feb 1, 2026

2019 – 2027

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
15
Facility City State ZIP Site status
Banner MD Anderson Cancer Center Gilbert Arizona 85234 Completed
City of Hope Duarte California 91010 Completed
H. Lee Moffitt Cancer Center Tampa Florida 33612 Recruiting
Winship Cancer Institute Emory University Atlanta Georgia 30322 Recruiting
Northside Hospital Cancer Institute Atlanta Georgia 30342 Recruiting
University of Maryland Baltimore Maryland 21201 Recruiting
Tufts Medical Center Boston Massachusetts 02111 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Completed
Barbara Ann Karmanos Cancer Institute (Wayne State University) Detroit Michigan 48201 Completed
University of Minnesota Minneapolis Minnesota 55455 Recruiting
Weill Cornell Medical College - NY Presbyterian Hospital New York New York 10021 Completed
Columbia University Irving Medical Center/New York Presbyterian Hospital New York New York 10032 Recruiting
Duke University Durham North Carolina 27708 Completed
Ohio State University Columbus Ohio 43210 Completed
Lifespan Cancer Institute at Rhode Island Hospital Providence Rhode Island 02903 Recruiting
Baylor University Medical Center Dallas Texas 75246 Recruiting
MD Anderson Houston Texas 77030 Completed
Medical College of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03666000, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 1, 2026 · Synced May 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03666000 live on ClinicalTrials.gov.

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