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NCT05665062 · ClinicalTrials.gov registry record · Phase 1
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
A Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Synthekine.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT05665062: Active Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Synthekine.
NCT05665062 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma that is active but no longer recruiting, run by Synthekine. The registered enrollment target is 36 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05665062, a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by Synthekine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
Primary Outcome
Incidence of adverse events (AEs) meeting protocol defined DLT criteria and determination of the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of STK-009 in combination with a fixed dose of SYNCAR-001
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG SYNCAR-001
- DRUG STK-009
Study Locations (4)
New York
- Roswell Park - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
California
- City of Hope - Duarte
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-04-23 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT05665062 still lists
NCT05665062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (83% lower).
The record links to 7 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT05665062 reports a single indexed study location in New York, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05665062 about?
NCT05665062 is a clinical study titled "Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies". This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
What is the current status of trial NCT05665062?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-04-23. Estimated completion is 2026-11.
What conditions does trial NCT05665062 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Large B-cell Lymphoma, NHL.
What interventions are being tested in trial NCT05665062?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), SYNCAR-001 (DRUG), STK-009 (DRUG).
Who is sponsoring clinical trial NCT05665062?
This trial is sponsored by Synthekine, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05665062 being conducted?
This trial has 4 study locations across California, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05665062's enrollment target sits among peer trials
36 72nd of 114 higher than 41 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B 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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