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Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
Phase 1, PHASE2 trial testing Autologous genetically modified T cells, NY-ESO-1ᶜ²⁵⁹T in Melanoma in 4 participants. Terminated before completion.
| Lead sponsor | Adaptimmune |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 1 June 2011 |
| Primary completion | 17 February 2016 |
| Estimated completion | 1 March 2018 |
| Sites | 2 locations across United States |
Adaptimmune — full company profile →
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants with NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3
| Group | Value | 95% CI |
|---|---|---|
| NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days | 3 |
Number of participants with response as assessed by RECIST (version 1.1) criteria.
| Group | Value | 95% CI |
|---|---|---|
| NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days | 0 |
Measurement of functionality of NY-ESO-1ᶜ²⁵⁹T cells in the blood and tumor sites.
| Group | Value | 95% CI |
|---|---|---|
| Subject 1 - Manufactured Product | 31.1354 | |
| Subject 1 - Day 60 | 61.545 | |
| Subject 2 - Manufactured Product | 18.65934 | |
| Subject 2 - Day 60 | 6.9 |
| Group | Value | 95% CI |
|---|---|---|
| Subject 1 - Manufactured Product | 14.62221 | |
| Subject 1 - Day 60 | 3.42 | |
| Subject 2 - Manufactured Product | 6.85214 | |
| Subject 2 - Day 60 | 6.9 |
| Group | Value | 95% CI |
|---|---|---|
| Subject 1 - Manufactured Product | 36.329 | |
| Subject 1 - Day 60 | 32.475 | |
| Subject 2 - Manufactured Product | 34.50644 | |
| Subject 2 - Day 60 | 82.7 |
| Group | Value | 95% CI |
|---|---|---|
| Subject 1 - Manufactured Product | 17.8215 | |
| Subject 1 - Day 60 | 2.56 | |
| Subject 2 - Manufactured Product | 39.99068 | |
| Subject 2 - Day 60 | 3.45 |
| Group | Value | 95% CI |
|---|---|---|
| Subject 1 - Manufactured Product | 0.40391 | |
| Subject 1 - Day 60 | 0 | |
| Subject 2 - Manufactured Product | 1.23488 | |
| Subject 2 - Day 60 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Subject 1 - Manufactured Product | 1.24694 | |
| Subject 1 - Day 60 | 0.855 | |
| Subject 2 - Manufactured Product | 4.11214 | |
| Subject 2 - Day 60 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Subject 1 - Manufactured Product | 97.74411 | |
| Subject 1 - Day 60 | 5.985 | |
| Subject 2 - Manufactured Product | 95.2126 | |
| Subject 2 - Day 60 | 10.35 |
Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)
| Group | Value | 95% CI |
|---|---|---|
| NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days | 56561.22 | 24984.1 – 126679 |
Time frame: Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NYESO-1ᶜ²⁵⁹T Cells Adminis… |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Pyrexia | General disorders | — |
| Platelet count decreased | Investigations | — |
| Reaction | System | NYESO-1ᶜ²⁵⁹T Cells Adminis… |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Anxiety | Psychiatric disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Candida infection | Infections and infestations | — |
| Cellulitis | Infections and infestations | — |
| Chills | General disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Depression | Psychiatric disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dysuria | Renal and urinary disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Headache | Nervous system disorders | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — |
| Insomnia | Psychiatric disorders | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — |
| Neuropathy peripheral | Nervous system disorders | — |
| Neutropenia decreased | Blood and lymphatic system disorders | — |
| Pancytopenia | Blood and lymphatic system disorders | — |
| Pollakiuria | Renal and urinary disorders | — |
| Skin Fissures | Skin and subcutaneous tissue disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
| Vitiligo | Skin and subcutaneous tissue disorders | — |
| Vomiting | Gastrointestinal disorders | — |
Most-reported serious reactions: Febrile neutropenia, Neutropenia, Pyrexia, Platelet count decreased.
Data from ClinicalTrials.gov NCT01350401 adverse events section.
The purpose of this early (phase I/II) clinical trial is to assess the effects (both good and bad) of genetically modified T cells after chemotherapy on your cancer and general health.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT01350401.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing