Clinical trial · Interventional
A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer
NCT03587285CI-TRIAL-00039853unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the feasibility, safety and oncological efficacy of hormonal therapy combined with autologous Tcm cells for patients with advanced 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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tcm+Goserelin acetate+Abiraterone acetate | Biological | — | UNRESOLVED |
| Tcm+ Goserelin acetate+ Bicalutamide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- metastatic hormone-sensitive prostate cancer (mHSPC):After diagnosis of mHSPC, patients receive infusions of autologous Tcm cells intravenously on Day 1 and Day 42, followed by hormonal therapy of maximal androgen blockade (LHRH-a + Anti-androgen).
- interventionNames
- Biological: Tcm+ Goserelin acetate+ Bicalutamide
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- metastatic castration-resistant prostate cancer (mCRPC):After diagnosis of mCRPC, patients receive infusions of autologous Tcm cells intravenously on Day 1 and Day 42, followed by goserelin acetate monthly. Abiraterone acetate 1000 mg orally daily plus prednisone 5 mg orally twice daily will be also administered continuously during the duration of the trial.
- interventionNames
- Biological: Tcm+Goserelin acetate+Abiraterone acetate
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who understand and sign the consent form for this study * Males age ≥18 years * Subjects diagnosed with metastatic hormone-sensitive prostate cancers (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Expected survival time of at least 24 months * Adequate hematologic, renal, and liver function: WBC greater than 3.5 x 109/L; Absolute neutrophils count greater than 1.5 x 109/L; Platelet count greater than 80 x 109/L; Hemoglobin at least 90g/L; AST less than 2 x upper limit of normal (ULN); Creatinine less than 1.5 x ULN * No obvious abnormalities in the electrocardiogram Exclusion Criteria: * Clinically significant cardiovascular disease: New York Heart Association (NYHA) class III or IV chronic congestive heart failure, coronary heart disease (myocardial infarction within 6 months); cardiac arrhythmia requiring anti-arrhythmic drug (beta-blocker or digoxin is allowed to be used); uncontrolled high blood pressure * HIV infection * Acute exacerbation of chronic hepatitis A or hepatitis B infection * The subject has uncontrollable seizures required pharmacotherapy (such as steroids or antiepileptic drugs) * The subject has a history of allogeneic organ transplants * Subject with irregular hemorrhagic disease * The subject receives dialysis treatment The subject has a history of other malignant tumor except subjects with curable basal cell carcinoma, superficial bladder tumor or other tumors has been cured over three years of study entry * The subject has a history of gastrointestinal hemorrhage within 30 days of study entry * The subject has an allergic history or is allergic to the drug in this study * The subject has serious diseases of respiratory, nervous or mental system * Subject with immune disease, auto-immune disease requires systemic ongoing immunosuppressive therapy * The subject has problems with drug or alcohol abuse * Major surgery within 4 weeks of enrollment * Prior autologous bone marrow transplantation within 4 weeks of enrollment * The subject has participated in any other therapeutic clinical trial with an experimental drug in the 4 weeks prior to this trial * The subject has any other unsuitable or adverse condition to be determined by the investigator * Any medical intervention or any circumstances that could compromise the safety and compliance of the trial subjects
References
Publications (0)
Data not yet available
No reference posted for this study.