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.
This is a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and tolerability, find an appropriate dose to optimize safety and efficacy, and evaluate clinical activity of azer-cel in participants with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL), non-Hodgkin lymphoma (NHL), and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Before initiating azer-cel, participants will be administered lymphodepletion (LD). At Day 0 of the Treatment Period, participants will receive an intravenous (IV) infusion of azer-cel potentially followed by interleukin-2 (IL-2). All participants will be monitored through D720 or progression. All participants who receive a dose of azer-cel will be asked to consent to a separate long-term follow-up (LTFU) study for up to 15 years after exiting this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Infusion of Allogeneic Anti-CD19 CAR T cells
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
COMPLETEDCity of Hope
Duarte, California, United States
COMPLETEDH. Lee Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGWinship Cancer Institute Emory University
Atlanta, Georgia, United States
RECRUITINGNorthside Hospital Cancer Institute
Atlanta, Georgia, United States
RECRUITINGUniversity of Maryland
Baltimore, Maryland, United States
RECRUITINGTufts Medical Center
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
COMPLETEDBarbara Ann Karmanos Cancer Institute (Wayne State University)
Detroit, Michigan, United States
COMPLETEDUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITING...and 13 more locations
Phase 1 Dose Escalation/Phase 1b Dose Expansion: Number of Participants with Azer-cel-related AEs Defined as Dose-limiting Toxicities (DLTs)
Time frame: Up to Day 720
Phase 1b Dose Expansion: Objective Response Rate (ORR) B-ALL
ORR for participants with B-ALL will be assessed by National Comprehensive Cancer Network (NCCN) 2017 criteria.
Time frame: Up to Day 720
Phase 1b Dose Expansion: ORR NHL
ORR for participants with NHL will be assessed by Lugano classification, International Workgroup on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines, International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, and International Workshop on Waldenstrom's Macroglobulinemia (IWWM)-11 criteria.
Time frame: Up to Day 720
Phase 1 Dose Escalation: ORR
* B-ALL: NCCN 2017 criteria * NHL: Lugano classification
Time frame: Up to Day 720
Complete Response (CR) Rate
* B-ALL: NCCN 2017 criteria * NHL: Lugano classification
Time frame: Up to day 720
Duration of Response (DoR)
\- Defined as the duration (days) from initial response to disease progression or death.
Time frame: Up to day 720
Progression-free survival (PFS)
\- Defined as the duration (days) from Day 0 to disease progression or death.
Time frame: Up to day 720
Overall survival (OS)
\- Defined as the duration (days) from Day 0 to death.
Time frame: Up to day 720
Time to next treatment (TNT)
\- Defined as the duration (days) from Day 0 to institution of next systemic therapy.
Time frame: Up to day 720
Number of Participants with AEs
\- Defined as all AEs of clinical significance captured on study and specific reporting of DLTs, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interests (AESIs), and AEs related to study treatment.
Time frame: Up to day 720
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