Clinical trial · Interventional
Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Advanced Ovarian Cancer
- 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)
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary peritoneal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Safety and toxicity
- measure
- Duration of in vivo persistence
- measure
- Antitumor effects
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria: * Progressive\* or persistent\* disease during or after primary chemotherapy * Recurrent disease \< 6 months after completion of primary therapy that had resulted in a complete response * Persistent\* or recurrent disease after second-line or additional therapies NOTE: \*Progression or persistence can be based on serological (CA 125 \> 100 U/mL OR 2 times baseline), radiographic (measurable or evaluable disease), or second-look surgical findings * Tumor expressing NY-ESO-1 determined by IHC or RT-PCR * HLA type expressing DPB\*0401, DPB1\*0201, DRB1\*07 * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 70-100% Life expectancy * More than 16 weeks Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No congestive heart failure\* * No clinically significant hypotension\* * No symptoms of coronary artery disease\* * No cardiac arrhythmias on EKG requiring drug therapy\* * No history of cardiovascular disease\* * No other significant cardiovascular abnormalities\* NOTE: \*Patients with any of the above undergo a stress test and/or echocardiography before being determined ineligible for study participation Pulmonary * FEV\_1 ≥ 60% of predicted\* * DLCO ≥ 55%\* NOTE: \*Patients with clinically significant pulmonary dysfunction only Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No active infection * No oral temperature \> 38.2°C within the past 72 hours * No systemic infection requiring chronic maintenance or suppressive therapy PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy (e.g., interleukins, interferons, vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior standard or experimental chemotherapy Endocrine therapy * No concurrent systemic corticosteroids except for treatment-related toxicity Radiotherapy * At least 3 weeks since prior radiotherapy Surgery * See Disease Characteristics Other * At least 3 weeks since prior immunosuppressive therapy * More than 3 weeks since prior investigational drugs and recovered * No other concurrent investigational agents * No concurrent pentoxifylline
References
Publications (0)
Data not yet available