RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2019-03-11
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03666000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Imugene Clinical Team
CONTACT
+1 984 245 0082
info@imugene.com
Imugene Clinical Team
CONTACT
+61 2 9423 0881
info@imugene.com

Principal Investigator

John Byon, MD, PhD
STUDY_CHAIR
Imugene Limited

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Imugene Limited

  • John Byon, MD, PhD, STUDY_CHAIR, Imugene Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-11
Study Completion Date2027-06

Study Record Updates

Study Start Date2019-03-11
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Hodgkin Lymphoma
  • B-cell Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma