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)
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03666000
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 135 participants
Conditions and interventions
Conditions
Interventions
- Azer-cel Biological
- Fludarabine Drug
- Cyclophosphamide Drug
- IL-2 Drug
- Ibrutinib, Acalabrutinib, Zanubrutinib, or Pirtobrutinib 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 11, 2019 (Actual)
- Primary completion
- Jun 2027 (Estimated)
- Completion
- Jun 2027 (Estimated)
- Last update posted
- Sep 8, 2026
2019 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Recruiting |
| Columbia University Irving Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | Recruiting |
| Lifespan Cancer Institute at Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| Baylor University Medical Center | Dallas | Texas | 75246 | Recruiting |
| 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 Sep 8, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03666000 live on ClinicalTrials.gov.