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NCT01140373 · ClinicalTrials.gov registry record · Phase 1
Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)
A Phase 1 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01140373: Active Phase 1 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01140373 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 13 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01140373, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. The investigators have found that T cells modified in this way were able to cure a cancer similar to Chronic Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.
Primary Outcome
Dose escalation is based on the dose limiting toxicity (DLT). In this phase I trial, dose escalation will be based on the DLT, defined as a grade 3 or 4 toxicity (excluding alopecia, fatigue) developing after infusion of the T cells as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Scale (CTCAE) Version 3.0. Only toxicities that are possibly, probably, or definitely related to treatment will be considered DLTs. Patients will be observed for DLTs four
Conditions Studied
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL engineered autologous T cells
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-06 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What the registry record for NCT01140373 still lists
NCT01140373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which cyclophosphamide is the first listed.
NCT01140373 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01140373 about?
NCT01140373 is a clinical study titled "Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)". This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune c...
What is the current status of trial NCT01140373?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2010-06. Estimated completion is 2026-06.
What conditions does trial NCT01140373 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01140373?
The interventions under investigation include: cyclophosphamide (DRUG), engineered autologous T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01140373?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01140373 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 Prostate Cancer
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 NCT01140373's enrollment target sits among peer trials
13 698th of 735 higher than 34 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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