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NCT05617755 · ClinicalTrials.gov registry record · Phase 1
AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer
A Phase 1 study of Ovarian Neoplasms and Peritoneal Neoplasms, sponsored by Arsenal Biosciences.
- Active
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 8
- Study locations
NCT05617755: Active Phase 1 study of Ovarian Neoplasms and Peritoneal Neoplasms, sponsored by Arsenal Biosciences.
NCT05617755 is a Phase 1 study of Ovarian Neoplasms and Peritoneal Neoplasms that is active but no longer recruiting, run by Arsenal Biosciences. The registered enrollment target is 19 participants, below the 367-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05617755, a Phase 1 study of Ovarian Neoplasms and Peritoneal Neoplasms, is active but no longer recruiting, sponsored by Arsenal Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a multi-center, open-label phase 1 dose escalation trial that uses a modified 3+3 design to identify a recommended phase 2 dose (RP2D) of AB-1015 cell product. Backfill cohorts will enroll additional subjects at doses deemed to be safe for a total enrollment of up to 12 subjects per each backfill cohort on the protocol.
Primary Outcome
Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events will be graded according to the criteria outlined in the protocol.
Conditions Studied
Interventions
- BIOLOGICAL AB-1015
Study Locations (8)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
California
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Colorado
- U of Colorado Cancer Center - Anschutz Medical Campus - Aurora
Iowa
- U of Iowa Health Care - Iowa City
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Texas
- MD Anderson Cancer Center - Houston
Washington
- U of Washington - Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What the registry record for NCT05617755 still lists
NCT05617755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 367-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (95% lower).
The record links to 9 conditions, with Ovarian Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which AB-1015 is the first listed.
NCT05617755 lists 8 locations in 7 states (New York, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT05617755 about?
NCT05617755 is a clinical study titled "AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer". This is a multi-center, open-label phase 1 dose escalation trial that uses a modified 3+3 design to identify a recommended phase 2 dose (RP2D) of AB-1015 cell product. Backfill cohorts will enroll additional subjects at doses deemed to be safe for a total enrollment of up to 12 subjects per each bac...
What is the current status of trial NCT05617755?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2022-11-29. Estimated completion is 2027-02.
What conditions does trial NCT05617755 study?
This clinical trial studies the following conditions: Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Recurrence, Carcinoma, Ovarian Epithelial.
What interventions are being tested in trial NCT05617755?
The interventions under investigation include: AB-1015 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05617755?
This trial is sponsored by Arsenal Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05617755 being conducted?
This trial has 8 study locations across California, Colorado, Iowa, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05617755's enrollment target sits among peer trials
19 36th of 38 higher than 1 of 38 other Ovarian Neoplasms trials
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