Clinical trial · Interventional
Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
NCT00664196CI-TRIAL-00022630suspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gene Modified T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: Gene Modified T Cells
Primary outcomes (1)
- measure
- Determine the safety of using modified T cells by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD)
- timeFrame
- 1 Month
Secondary outcomes (3)
- measure
- Tumor Response
- timeFrame
- 1 Month
- measure
- Pharmacokinetics
- timeFrame
- 1 Month
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of prostate cancer 2. Elevated PSA 3. Life expectancy \> 4 months 4. Performance status 0-1 5. ANC 1.0 6. Platelets \> 100,000 7. Hemoglobin \> 8.0 8. Creatinine \< 1.5mg/dl 9. Direct Bilirubin \< 1.5 mg/dl 10. No evidence of CHF, CAD, cardiac arrhythmias, A-fib, A flutter, myocardial infarction. 11. No serious, symptomatic obstructive or emphysematous lung disease 12. No asthma requiring IV medication during last 12 months, no serious lung disease associated with dyspnea at normal activity levels, or at rest due to any cause, including cancer metastasis and pleural effusion 13. Patients must have a biopsy able tumor, and be willing to undergo biopsy (Group 3 only) 14. Patient is at least 18 years of age. Exclusion Criteria: 1. Serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam 2. Active clinical disease caused by CMV, Hepatitis B, or C, HIV, TB 3. Cytotoxic and/or radiation therapy during last 4 weeks prior to entry 4. Any concurrent malignancies 5. Patient requires systemic steroids 6. Patient has participated in prior investigational therapy 7. Patient has prior exposure to mouse antibody 8. Patient has had irradiation to whole pelvis or \>25% marrow
References
Publications (0)
Data not yet available
No reference posted for this study.