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NCT04450069 · ClinicalTrials.gov registry record · Phase 1
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
A Phase 1 study of Mantle Cell Lymphoma and Waldenstrom Macroglobulinemia, sponsored by Calibr, a division of Scripps Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 8
- Study locations
NCT04450069: Completed Phase 1 study of Mantle Cell Lymphoma and Waldenstrom Macroglobulinemia, sponsored by Calibr, a division of Scripps Research.
NCT04450069 is a Phase 1 study of Mantle Cell Lymphoma and Waldenstrom Macroglobulinemia that has completed, run by Calibr, a division of Scripps Research. The registered enrollment target is 18 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (83% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04450069, a Phase 1 study of Mantle Cell Lymphoma and Waldenstrom Macroglobulinemia, has completed, sponsored by Calibr, a division of Scripps Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 8
- Study locations
Study Summary
CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation. This first-in-human study will assess the safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.
Primary Outcome
To determine the frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events
Conditions Studied
Interventions
- COMBINATION_PRODUCT CLBR001 and SWI019
Study Locations (8)
California
- City of Hope National Medical Center - Duarte
- University of California at San Diego - San Diego
Illinois
- University of Chicago - Chicago
Minnesota
- Masonic Cancer Center, University of Minnesota - Minneapolis
New York
- Weill Cornell Medical College - New York Presbyterian Hospital - New York
North Carolina
- Wake Forest Baptist Health - Winston-Salem
Tennessee
- Sarah Cannon Research Institute - Tennessee Oncology - Nashville
Texas
- Sarah Cannon Research Institute - Texas Transplant Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-08-14 |
| Est. Completion | 2024-05-06 |
| Phase | Phase 1 |
What the finished NCT04450069 record still lists
NCT04450069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (83% lower).
The record links to 10 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which CLBR001 and SWI019 is the first listed.
NCT04450069 lists 8 locations in 7 states (California, Illinois, Minnesota).
Frequently Asked Questions
What is clinical trial NCT04450069 about?
NCT04450069 is a clinical study titled "CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies". CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell trans...
What is the current status of trial NCT04450069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-08-14. Estimated completion is 2024-05-06.
What conditions does trial NCT04450069 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Primary Mediastinal Large B Cell Lymphoma.
What interventions are being tested in trial NCT04450069?
The interventions under investigation include: CLBR001 and SWI019 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04450069?
This trial is sponsored by Calibr, a division of Scripps Research, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04450069 being conducted?
This trial has 8 study locations across California, Illinois, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04450069's enrollment target sits among peer trials
18 90th of 102 higher than 12 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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