Clinical trial · Interventional
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors
NCT03970382CI-TRIAL-00060401suspendedPhase 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): Business decision
Summary
Brief summary (as posted)
This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-2 | Biological | — | UNRESOLVED |
| NeoTCR-P1 adoptive cell therapy | Biological | — | UNRESOLVED |
| nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NeoTCR-P1
- description
- Single dose of NeoTCR-P1
- interventionNames
- Biological: NeoTCR-P1 adoptive cell therapy
- type
- EXPERIMENTAL
- label
- NeoTCR-P1 plus nivolumab
- description
- Single dose of NeoTCR-P1 plus nivolumab 480mg IV every four weeks for up to 6 doses.
- interventionNames
- Biological: NeoTCR-P1 adoptive cell therapy
- Biological: nivolumab
- type
- EXPERIMENTAL
- label
- NeoTCR-P1 plus IL-2
- description
- Single dose of NeoTCR-P1 plus IL-2 500,000 IU/m2 SC twice daily (BID) for 7 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer. * Disease has progressed after at least one available standard therapy or no additional curative therapies are available. * Measurable disease per RECIST v1.1 * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Adequate hematologic and end organ function determined within 30 days prior to enrollment. * Disease-specific criteria related to the specific tumor type are required. Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria. Exclusion Criteria: * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease * Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases * Uncontrolled or symptomatic hypercalcemia * Pregnancy, lactation, or breastfeeding * Prior allogeneic stem cell transplant or solid organ transplant * Prior chimeric antigen receptor therapy or other genetically modified T cell therapy * Active HIV, Hepatitis B, or Hepatitis C infection * Active tuberculosis * Severe infection within 2 weeks prior to enrollment * Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study. Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.
References
Publications (2)
- DERIVEDFoy SP, Jacoby K, Bota DA, Hunter T, Pan Z, Stawiski E, Ma Y, Lu W, Peng S, Wang CL, Yuen B, Dalmas O, Heeringa K, Sennino B, Conroy A, Bethune MT, Mende I, White W, Kukreja M, Gunturu S, Humphrey E, Hussaini A, An D, Litterman AJ, Quach BB, Ng AHC, Lu Y, Smith C, Campbell KM, Anaya D, Skrdlant L, Huang EY, Mendoza V, Mathur J, Dengler L, Purandare B, Moot R, Yi MC, Funke R, Sibley A, Stallings-Schmitt T, Oh DY, Chmielowski B, Abedi M, Yuan Y, Sosman JA, Lee SM, Schoenfeld AJ, Baltimore D, Heath JR, Franzusoff A, Ribas A, Rao AV, Mandl SJ. Non-viral precision T cell receptor replacement for personalized cell therapy. Nature. 2023 Mar;615(7953):687-696. doi: 10.1038/s41586-022-05531-1. Epub 2022 Nov 10. PMID 36356599
- DERIVEDLevy PL, Gros A. Fast track to personalized TCR T cell therapies. Cancer Cell. 2022 May 9;40(5):447-449. doi: 10.1016/j.ccell.2022.04.013. Epub 2022 May 9. PMID 35537408