Clinical trial · Interventional
Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer
A Phase-1 Trial of Adoptive Transfer of Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Combined With Vaccine Boost and Bevacizumab for Recurrent Ovarian Fallopian Tube or Primary Peritoneal Cancer Previously Vaccinated With Autologous Tumor Vaccine
- 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)
This is a phase-I clinical trial to determine the feasibility and safety of Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole tumor vaccine administered intradermally in combination with Bevacizumab in patients with recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA OOPD)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| cyclophosphamide 300 mg/m2/d for 3 days | Drug | — | UNRESOLVED |
| ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells | Drug | — | UNRESOLVED |
| fludarabine 30 mg/m2/d for 3 days | Drug | — | UNRESOLVED |
| OC-DC vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Dose Limiting Toxicity
- timeFrame
- 5 Years
- description
- Dose limiting toxicity is defined as the occurrence of treatment-related adverse events.
Secondary outcomes (1)
- measure
- Tumor response
- timeFrame
- 5 years
- description
- Tumor response will be estimated by measures of tumor burden and survival.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who have received at least one vaccine under protocol UPCC-19809 or UPCC-29810. * ECOG performance status 0 or 1. * Subject has sufficient vaccine (2 vaccine doses are sufficient) * Must be at least 4 weeks post-operative * Blood coagulation parameters: PT such that international normalized ratio (INR) is less than1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than1.2 times the upper limit of normal. * Subject must be 18 years of age or older. * Life expectancy of greater than 4 months. * Normal organ and bone marrow function as defined by: Absolute neutrophil count greater than 1,000/microliter, Platelets greater than 100,000/microliter, Hematocrit greater than 30%, AST (SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal, Bilirubin less than 2.0 mg/dL unless secondary to bile duct blockage by tumor, and Creatinine less than 1.8 mg/dL Exclusion Criteria: * Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness. Subjects must complete therapy prior to enrollment. Topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment. * Subjects with any acute infection that requires specific therapy. Acute therapy must have been completed at least seven days prior to study enrollment * Subjects with any underlying conditions, which would contraindicate therapy with, study treatment (or allergies to reagents used in this study). * Subjects with prior history or symptoms suggestive of partial or complete bowel obstruction. * Subjects receiving class III antiarrythmic medications. * Subjects receiving medications that might affect immune function. Additionally, H2 blockers are excluded, as are all antihistamines five days before and five days after each injection of study drug. NOTE: The following are exceptions: Proton pump Inhibitors (PPIs), NSAIDS including COX-2 inhibitors, acetaminophen. * Subjects who are allergic to Aspirin are excluded * Development of clinically significant co morbid disease that would contraindicate study therapy or confuse interpretation of study results. * Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. * Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
References
Publications (1)
- DERIVEDBobisse S, Bianchi V, Tanyi JL, Sarivalasis A, Missiaglia E, Petremand R, Benedetti F, Torigian DA, Genolet R, Barras D, Michel A, Mastroyannis SA, Zsiros E, Dangaj Laniti D, Tsourti Z, Stevenson BJ, Iseli C, Levine BL, Speiser DE, Gfeller D, Bassani-Sternberg M, Powell DJ Jr, June CH, Dafni U, Kandalaft LE, Harari A, Coukos G. A phase 1 trial of adoptive transfer of vaccine-primed autologous circulating T cells in ovarian cancer. Nat Cancer. 2023 Oct;4(10):1410-1417. doi: 10.1038/s43018-023-00623-x. Epub 2023 Sep 21. PMID 37735588