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NCT03331198 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
A Phase 1 study of Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Small Lymphocytic, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 320
- Enrollment target
- 20
- Study locations
NCT03331198 is a Phase 1 study of Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Small Lymphocytic that is actively recruiting participants, run by Juno Therapeutics, a Subsidiary of Celgene. The registered enrollment target is 320 participants, below the 462-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT03331198, a Phase 1 study of Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Small Lymphocytic, is actively recruiting participants, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 320 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.
Conditions Studied
Interventions
- BIOLOGICAL JCAR017 (lisocabtagene maraleucel)
- BIOLOGICAL JCAR017 (lisocabtagene maraleucel) + ibrutinib
- BIOLOGICAL JCAR017 (lisocabtagene maraleucel) + venetoclax
Study Locations (20)
California
- City of Hope - Duarte
- City Of Hope - Duarte
- UC San Diego Moores Cancer Center - La Jolla
- University Of California San Diego Moores Cancer Center - La Jolla
- Local Institution - 0059 - Los Angeles
- University of California, Los Angeles - Los Angeles
- Local Institution - 0010 - San Francisco
- University of California, San Francisco - San Francisco
Alabama
- University of Alabama at Birmingham - Birmingham
- University of Alabama Birmingham - Birmingham
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Banner MD Anderson Cancer Center - Gilbert
District of Columbia
- Georgetown University Medical Center - Washington D.C.
- Local Institution - 0085 - Washington D.C.
Florida
- Mayo Clinic - Jacksonville - Jacksonville
- Mayo Clinic - Jacksonville
Georgia
- Local Institution - 0104 - Atlanta
- Local Institution - 0019 - Atlanta
Colorado
- Colorado Blood Cancer Institute - Denver
Delaware
- Local Institution - 0110 - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2027-11-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03331198
The ClinicalTrials.gov registry entry for NCT03331198 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 462-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (31% lower). The listed sponsor is Juno Therapeutics, a Subsidiary of Celgene, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Leukemia, Lymphocytic, Chronic, B-Cell appearing as the primary indexed condition, and to 3 interventions - of which JCAR017 (lisocabtagene maraleucel) is the first listed.
NCT03331198 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT03331198 about?
NCT03331198 is a clinical study titled "Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)". This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or S...
What is the current status of trial NCT03331198?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2017-11-27. Estimated completion is 2027-11-26.
What conditions does trial NCT03331198 study?
This clinical trial studies the following conditions: Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Small Lymphocytic.
What interventions are being tested in trial NCT03331198?
The interventions under investigation include: JCAR017 (lisocabtagene maraleucel) (BIOLOGICAL), JCAR017 (lisocabtagene maraleucel) + ibrutinib (BIOLOGICAL), JCAR017 (lisocabtagene maraleucel) + venetoclax (BIOLOGICAL).
Who is sponsoring clinical trial NCT03331198?
This trial is sponsored by Juno Therapeutics, a Subsidiary of Celgene, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03331198 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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