OncoMatch/Clinical Trials/NCT03666000
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)
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)
Is NCT03666000 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments for non-hodgkin lymphoma.
Treatment: Azer-cel · Fludarabine · Cyclophosphamide · IL-2 · Ibrutinib, Acalabrutinib, Zanubrutinib, or Pirtobrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 expression
r/r CD19+ B-ALL; aggressive CD19+ r/r B-cell NHL
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- H. Lee Moffitt Cancer Center · Tampa, Florida
- Winship Cancer Institute Emory University · Atlanta, Georgia
- Northside Hospital Cancer Institute · Atlanta, Georgia
- University of Maryland · Baltimore, Maryland
- Tufts Medical Center · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03666000 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify