Last reviewed · How we verify
NCT03691376
Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase 1 trial testing Aldesleukin in Platinum-Resistant Fallopian Tube Carcinoma in 4 participants. Terminated before completion.
30 January 2021
Quick facts
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 8 March 2019 |
| Primary completion | 30 January 2021 |
| Estimated completion | 24 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aldesleukin (ALDESLEUKIN) — full drug profile →
- Autologous NY-ESO-1-specific CD8-positive T Lymphocytes — full drug profile →
- Cellular Therapy — full drug profile →
- Melphalan (melphalan) — full drug profile →
Conditions studied
- Platinum-Resistant Fallopian Tube Carcinoma — all drugs for Platinum-Resistant Fallopian Tube Carcinoma →
- Platinum-Resistant Ovarian Carcinoma — all drugs for Platinum-Resistant Ovarian Carcinoma →
- Platinum-Resistant Primary Peritoneal Carcinoma — all drugs for Platinum-Resistant Primary Peritoneal Carcinoma →
- Platinum-Sensitive Fallopian Tube Carcinoma — all drugs for Platinum-Sensitive Fallopian Tube Carcinoma →
Sponsor
Roswell Park Cancer Institute
Who can join
18 and older, female only, with Platinum-Resistant Fallopian Tube Carcinoma or Platinum-Resistant Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the best dose and side effects of NY-ESO-1 T cell receptor (TCR) engineered T cells and how well they work with NY-ESO-1 TCR engineered hematopoietic stem cells (HSCs) after melphalan conditioning regimen in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) or does not respond to treatment (refractory). The melphalan conditioning chemotherapy makes room in the patient's bone marrow for new blood cells and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR T cells and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer. Giving NY-ESO-1 TCR engineered T cells and HSCs after melphalan may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Engineered T Cell Therapy for Cancer in the Clinic.
Zhao L, Cao YJ. · · 2019 · cited 275× · PMID 31681259 · DOI 10.3389/fimmu.2019.02250 -
T-cell receptor-based therapy: an innovative therapeutic approach for solid tumors.
Tsimberidou AM, Van Morris K, Vo HH, Eck S, et al · · 2021 · cited 119× · PMID 34193217 · DOI 10.1186/s13045-021-01115-0 -
Adoptive cellular immunotherapy for solid neoplasms beyond CAR-T.
Liu Q, Li J, Zheng H, Yang S, et al · · 2023 · cited 102× · PMID 36750830 · DOI 10.1186/s12943-023-01735-9 -
Engineered TCR-T Cell Immunotherapy in Anticancer Precision Medicine: Pros and Cons.
Zhao Q, Jiang Y, Xiang S, Kaboli PJ, et al · · 2021 · cited 97× · PMID 33859650 · DOI 10.3389/fimmu.2021.658753 -
Biology of Cancer-Testis Antigens and Their Therapeutic Implications in Cancer.
Nin DS, Deng LW. · · 2023 · cited 45× · PMID 36980267 · DOI 10.3390/cells12060926 -
T Cell Based Immunotherapy for Cancer: Approaches and Strategies.
Want MY, Bashir Z, Najar RA. · · 2023 · cited 44× · PMID 37112747 · DOI 10.3390/vaccines11040835 -
T-Cell Receptor Therapy in the Treatment of Ovarian Cancer: A Mini Review.
Wu JWY, Dand S, Doig L, Papenfuss AT, et al · · 2021 · cited 40× · PMID 33927729 · DOI 10.3389/fimmu.2021.672502 -
Evolution of CD8<sup>+</sup> T Cell Receptor (TCR) Engineered Therapies for the Treatment of Cancer.
Sun Y, Li F, Sonnemann H, Jackson KR, et al · · 2021 · cited 34× · PMID 34572028 · DOI 10.3390/cells10092379
Verify or expand the search:
- PubMed search for NCT03691376
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aldesleukin
Trials testing the same drug.
- NCT07389239 — A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies. · Phase 1, PHASE2 · not yet recruiting
- NCT06626256 — STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Ca · Phase 1 · withdrawn
- NCT06690281 — A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced · Phase 2 · withdrawn
- NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
- NCT05989828 — A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple N · Phase 1 · suspended
Other recruiting trials for Platinum-Resistant Fallopian Tube Carcinoma
Currently open trials in the same condition.
- NCT06483048 — MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer · Phase 1 · recruiting
- NCT05538091 — Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer · Phase 2 · recruiting
- NCT05465941 — PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer · Phase 2 · recruiting
- NCT04781088 — Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or · Phase 2 · active not recruiting
- NCT04616534 — Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gem · Phase 1 · active not recruiting
Other Roswell Park Cancer Institute trials
Trials by the same sponsor.
- NCT07489287 — GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer · Phase 1 · not yet recruiting
- NCT06943664 — Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-I · Phase 2 · not yet recruiting
- NCT06827054 — Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids · Phase 2 · not yet recruiting
- NCT06334016 — Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream · EARLY_PHASE1 · not yet recruiting
- NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03691376 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Roswell Park Cancer Institute
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03691376.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing