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Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01350401
Recruitment Status : Terminated (Lack of enrollment)
First Posted : May 9, 2011
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Genetic: Autologous genetically modified T cells, NY-ESO-1ᶜ²⁵⁹T
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
49
(41 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Adverse Events Related to Study Treatment
Hide Description Number of Participants with NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3
Time Frame Up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received cytoreductive chemotherapy followed by IV infusion of NY-ESO-1ᶜ²⁵⁹T
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2.Secondary Outcome
Title Tumor Response
Hide Description Number of participants with response as assessed by RECIST (version 1.1) criteria.
Time Frame Change from Baseline, every 4 weeks until Month 5 and then every other month through Month 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Determine the Functional Properties and Phenotype of Modified T-cells From Peripheral Blood and Tumor Sites.
Hide Description Measurement of functionality of NY-ESO-1ᶜ²⁵⁹T cells in the blood and tumor sites.
Time Frame 8 Weeks post T-cell infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with functionality data
Arm/Group Title Subject 1 - Manufactured Product Subject 1 - Day 60 Subject 2 - Manufactured Product Subject 2 - Day 60
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1 1 1
Overall Number of Units Analyzed
Type of Units Analyzed: T-cell sub population
7 7 7 7
Measure Type: Number
Unit of Measure: percentage of T cell sub population
%Stem Cell Memory 31.1354 61.545 18.65934 6.9
%Central Memory 14.62221 3.42 6.85214 6.9
%Effector Memory RA 36.329 32.475 34.50644 82.7
%Effector Memory 17.8215 2.56 39.99068 3.45
%LAG-3+ 0.40391 0 1.23488 0
%PD-1+ 1.24694 0.855 4.11214 0
%TIM-3+ 97.74411 5.985 95.2126 10.35
4.Secondary Outcome
Title Peak Persistence of Modified T-cells in the Peripheral Blood
Hide Description Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)
Time Frame Days 1, 5-9, 12-16, weekly thereafter through Week 12, monthly thereafter through Month 12, and during LTFU
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with persistence data
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: copies per μg of DNA
56561.22
(24984.1 to 126679)
Time Frame Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Adverse Event Reporting Description Participants who received NY-ESO-1ᶜ²⁵⁹T
 
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
All-Cause Mortality
NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Affected / at Risk (%)
Total   3/4 (75.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  2/4 (50.00%)  4
Neutropenia * 1  2/4 (50.00%)  4
General disorders   
Pyrexia * 1  1/4 (25.00%)  4
Investigations   
Platelet count decreased * 1  1/4 (25.00%)  4
1
Term from vocabulary, MedDRA version 18
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  2/4 (50.00%)  2
Neutropenia decreased * 1  1/4 (25.00%)  1
Pancytopenia * 1  1/4 (25.00%)  1
Thrombocytopenia * 1  1/4 (25.00%)  1
Cardiac disorders   
Supraventricular tachycardia * 1  1/4 (25.00%)  1
Gastrointestinal disorders   
Nausea * 1  3/4 (75.00%)  3
Constipation * 1  2/4 (50.00%)  2
Diarrhea * 1  1/4 (25.00%)  1
Vomiting * 1  1/4 (25.00%)  1
General disorders   
Fatigue * 1  4/4 (100.00%)  4
Pyrexia * 1  2/4 (50.00%)  2
Chills * 1  1/4 (25.00%)  1
Infections and infestations   
Candida infection * 1  1/4 (25.00%)  1
Cellulitis * 1  1/4 (25.00%)  1
Urinary Tract Infection * 1  1/4 (25.00%)  1
Investigations   
Alanine aminotransferase increased * 1  1/4 (25.00%)  1
Aspartate aminotransferase increased * 1  1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain * 1  1/4 (25.00%)  1
Nervous system disorders   
Dizziness * 1  1/4 (25.00%)  1
Headache * 1  1/4 (25.00%)  1
Neuropathy peripheral * 1  1/4 (25.00%)  1
Psychiatric disorders   
Anxiety * 1  1/4 (25.00%)  1
Depression * 1  1/4 (25.00%)  1
Insomnia * 1  1/4 (25.00%)  1
Renal and urinary disorders   
Dysuria * 1  1/4 (25.00%)  1
Hematuria * 1  1/4 (25.00%)  1
Pollakiuria * 1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
Rash * 1  3/4 (75.00%)  3
Alopecia * 1  2/4 (50.00%)  2
Hyperhidrosis * 1  1/4 (25.00%)  1
Skin Fissures * 1  1/4 (25.00%)  1
Vitiligo * 1  1/4 (25.00%)  1
1
Term from vocabulary, MedDRA version 18
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Trials Management
Organization: Adaptimmune
Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT01350401     History of Changes
Other Study ID Numbers: ADP 01611
First Submitted: May 2, 2011
First Posted: May 9, 2011
Results First Submitted: January 11, 2018
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018