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Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients With r/r NHL and r/r B-cell ALL
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 and r/r B-cell NHL.
Study details:
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) and non-Hodgkin lymphoma (NHL). 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.
All participants will be monitored through D720 or progression. All participants who receive a dose of azer-cel will be followed in a separate long-term follow-up (LTFU) study for up to 15 years after exiting this study.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2019-03-11
Primary completion: 2025-06-01
Study completion finish: 2027-06-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT03666000
Intervention or treatment
BIOLOGICAL: Azer-cel
DRUG: Fludarabine
DRUG: Cyclophosphamide
DRUG: IL-2
DRUG: Bendamustine
Conditions
- • Non-Hodgkin Lymphoma
- • B-cell Acute Lymphoblastic Leukemia
Find a site
Closest Location:
Royal Prince Alfred Hospital
Research sites nearby
Select from list below to view details:
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Level 1
| BIOLOGICAL: Azer-cel
|
EXPERIMENTAL: Dose Level 2
| BIOLOGICAL: Azer-cel
|
EXPERIMENTAL: Dose Level 3a
| BIOLOGICAL: Azer-cel
|
EXPERIMENTAL: Dose Level 4
| BIOLOGICAL: Azer-cel
|
EXPERIMENTAL: Dose Level 4b
| BIOLOGICAL: Azer-cel
|
EXPERIMENTAL: Dose level 4c
| BIOLOGICAL: Azer-cel
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Phase 1 Dose Escalation/Phase 1b Dose Expansion: Frequency of Participants with Azer-cel related Adverse Events (AEs) defined as dose limiting toxicities (DLTs) | Not Specified | Up to day 720 |
Phase 1b Dose Expansion: Objective response rate (ORR): Dose expansion only | - NHL: Lugano criteria | Up to day 720 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Objective Response Rate (ORR): Dose escalation only | * B-ALL: National Comprehensive Cancer Network (NCCN) 2017 criteria * NHL: Lugano criteria | Up to day 720 |
Complete response (CR) rate | * B-ALL: National Comprehensive Cancer Network (NCCN) 2017 criteria * NHL: Lugano criteria | Up to day 720 |
Duration of Response (DoR) | - Defined as the duration (days) from initial response to disease progression or death. | Up to day 720 |
Progression-free survival (PFS) | - Defined as the duration (days) from Day 0 to disease progression or death. | Up to day 720 |
Overall survival (OS) | - Defined as the duration (days) from Day 0 to death. | Up to day 720 |
Time to next treatment (TNT) | - Defined as the duration (days) from Day 0 to institution of next systemic therapy. | 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. | Up to day 720 |
Frequently Asked Questions
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