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NCT03666000 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, sponsored by Imugene Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 135
- Enrollment target
- 20
- Study locations
NCT03666000 is a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma that is actively recruiting participants, run by Imugene Limited. The registered enrollment target is 135 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT03666000, a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Imugene Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 135 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Azer-cel
- DRUG IL-2
Study Locations (20)
Georgia
- Winship Cancer Institute Emory University - Atlanta
- Northside Hospital Cancer Institute - Atlanta
Massachusetts
- Tufts Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Weill Cornell Medical College - NY Presbyterian Hospital - New York
- Columbia University Irving Medical Center/New York Presbyterian Hospital - New York
Texas
- Baylor University Medical Center - Dallas
- MD Anderson - Houston
New South Wales
- Royal Prince Alfred Hospital - Camperdown
- Liverpool Hospital - Liverpool
Arizona
- Banner MD Anderson Cancer Center - Gilbert
California
- City of Hope - Duarte
Florida
- H. Lee Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03666000
The ClinicalTrials.gov registry entry for NCT03666000 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (25% lower). The listed sponsor is Imugene Limited, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03666000 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Georgia, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT03666000 about?
NCT03666000 is a clinical study titled "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)". 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.
What is the current status of trial NCT03666000?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2019-03-11. Estimated completion is 2027-06.
What conditions does trial NCT03666000 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, Small Lymphocytic Lymphoma, B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT03666000?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Azer-cel (BIOLOGICAL), IL-2 (DRUG).
Who is sponsoring clinical trial NCT03666000?
This trial is sponsored by Imugene Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03666000 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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