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NCT02498912 · ClinicalTrials.gov registry record · Phase 1
Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors
A Phase 1 study of Solid Tumors, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02498912: Active Phase 1 study of Solid Tumors, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02498912 is a Phase 1 study of Solid Tumors that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 18 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02498912, a Phase 1 study of Solid Tumors, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected called "modified T cells". In the screening part of this study the tumor was found to have a protein called MUC16. This protein is present on about 70% of ovarian cancers. The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard chemotherapy. We also want to find out what effects these modified T cells have on the patient and their cancer.
Primary Outcome
There are 5 planned dose levels of 4H11-28z/fIL-12/EGFRt+ T cells: 3 x 10\^5, 1 x 10\^6, 3 x 10\^6, and 1 x10\^7 and 3 x10\^7 4H11-28z/fIL-12/EGFRt+ T cells/kg. The first subject will be treated at dose level 1 (3 x 10\^5 4H11-28z/fIL-12/EGFRt+ T cells/kg). At least one week will elapse from the first patient's T cell infusions before the second patient is treated (on dose level 1) to allow for toxicity and safely assessment. 3 subjects will be enrolled in cohort I and followed for 30 days for s
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Production of Genetically-modified T cells
- DEVICE IP Catheter Insertion
- GENETIC Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-08 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What the registry record for NCT02498912 still lists
NCT02498912 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 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02498912 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02498912 about?
NCT02498912 is a clinical study titled "Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors". The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected called "modified T cells". In the screening part of this study the tumor was found to have a protein called MUC16. This protein is present on about 70% of ovarian cancers. The inves...
What is the current status of trial NCT02498912?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-08. Estimated completion is 2026-08.
What conditions does trial NCT02498912 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT02498912?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Production of Genetically-modified T cells (PROCEDURE), IP Catheter Insertion (DEVICE), Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells (GENETIC).
Who is sponsoring clinical trial NCT02498912?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02498912 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02498912's enrollment target sits among peer trials
18 117th of 125 higher than 9 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
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-
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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
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Study of AUBE00 in Patients With Solid Tumors
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