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CT Antigen TCR-redirected T Cells for Ovarian Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01567891
Recruitment Status : Active, not recruiting
First Posted : March 30, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
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 Ovarian Cancer
Intervention Biological: NYESO-1c259 T cells
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T Cells Administered Intravenously
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by Lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5 billion cells)
Period Title: Overall Study
Started 9
Received T-cell 6
Completed 6
Not Completed 3
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
Overall Number of Baseline Participants 6
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 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  83.3%
>=65 years
1
  16.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
58
(52 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
6
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 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
6
 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 Adverse Events related to study treatment
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
5
  83.3%
2.Secondary Outcome
Title Tumor Response
Hide Description Number of participants with response as assessed by Immune-related Response Criteria (irRC)
Time Frame Change from baseline, every 4 weeks until month 3 and then every 3 month until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Peak Persistence of Modified T-cells in the Peripheral Blood
Hide Description Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood
Time Frame Days: 1, 2-4, weeks 1 to 4, Week 8, 12 and Month 6, then every 3 months thereafter until progression then during LTFU
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NY-ESO-1ᶜ²⁵⁹T
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T
Hide Arm/Group Description:
Participants who received NY-ESO-1ᶜ²⁵⁹T
Overall Number of Participants Analyzed 6
Mean (Full Range)
Unit of Measure: copies of WPRE/mcg of genomic PBMC DNA
85862.6
(27,310 to 169,753)
4.Secondary Outcome
Title Determine Functional Properties and Phenotype of Modified T-cells From Peripheral Blood.
Hide Description Percentage of CD4+pentamer+ or CD8+pentamer+ cells expressing LAG-3, PD-1, TIM-3 in the functionality of NY-ESO-1ᶜ²⁵⁹T cells in the manufactured product and post-treatment blood.
Time Frame Weeks 4 and 8 post T-cell infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manufactured Product -Mean % CD4+Pentamer+ Week 4 Post-treatment- Mean % CD4+Pentamer+ Week 8 Post-treatment - Mean % CD4+Pentamer+ Manufactured Product - Mean % CD8+Pentamer+ Week 4 Post-treatment - Mean % CD8+Pentamer+ Week 8 Post-treatment - Mean % CD8+Pentamer+
Hide Arm/Group Description:
Participants who received NY-ESO-1ᶜ²⁵⁹T
Participants who received NY-ESO-1ᶜ²⁵⁹T
Participants who received NY-ESO-1ᶜ²⁵⁹T
Participants who received NY-ESO-1ᶜ²⁵⁹T
Participants who received NY-ESO-1ᶜ²⁵⁹T
Participants who received NY-ESO-1ᶜ²⁵⁹T
Overall Number of Participants Analyzed 5 5 5 5 5 5
Overall Number of Units Analyzed
Type of Units Analyzed: T-cell sub population
3 3 3 3 3 3
Measure Type: Number
Unit of Measure: percentage of T cell sub population
%LAG-3 4 3 0 3 0 0
%PD-1 6 0 3 1 1 4
%TIM-3 97 17 11 97 24 7
5.Secondary Outcome
Title Correlate NY-ESO-1 Expression in Tumor Tissue Before Treatment With Archival Tumor Tissue to Assess Impact of Therapy on Expression of NY-ESO-1 Protein
Hide Description

NY-ESO-1 expression as determined by Histoscore (H score). Histoscore (0-300) represents the amount of NY-ESO-1 protein present in the tissue sample.

H-Score formula:

[1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)]

(It is not clearly established if NY-ESO-1 H score has an association with prognosis.)

Time Frame Screening and at Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data is presented for 2 subjects, 4 subjects declined Baseline biopsy or biopsy wasn't collected due to safety concerns
Arm/Group Title Subject 1 Subject 2
Hide Arm/Group Description:
Participants who received NY-ESO-1ᶜ²⁵⁹T
Participants who received NY-ESO-1ᶜ²⁵⁹T
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: H score
Screening/Archival 50 100
Baseline 15 0
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 NY-ESO-1ᶜ²⁵⁹T
Hide Arm/Group Description Participants who received NY-ESO-1ᶜ²⁵⁹T
All-Cause Mortality
NY-ESO-1ᶜ²⁵⁹T
Affected / at Risk (%)
Total   6/6 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
NY-ESO-1ᶜ²⁵⁹T
Affected / at Risk (%) # Events
Total   5/6 (83.33%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  3/6 (50.00%)  6
Pancytopenia * 1  1/6 (16.67%)  6
General disorders   
Disease Progression * 1  1/6 (16.67%)  6
Pyrexia * 1  1/6 (16.67%)  6
Immune system disorders   
Cytokine Release Syndrome * 1  2/6 (33.33%)  6
Metabolism and nutrition disorders   
Dehydration * 1  1/6 (16.67%)  6
Nervous system disorders   
Presyncope * 1  1/6 (16.67%)  6
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%
NY-ESO-1ᶜ²⁵⁹T
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  2/6 (33.33%)  6
Lymphademopathy * 1  1/6 (16.67%)  6
Lymphopenia * 1  1/6 (16.67%)  6
Thrombocytopenia * 1  1/6 (16.67%)  6
Cardiac disorders   
Sinus Tachycardia * 1  2/6 (33.33%)  6
Gastrointestinal disorders   
Nausea * 1  4/6 (66.67%)  6
Abdominal Pain * 1  3/6 (50.00%)  6
Ascites * 1  2/6 (33.33%)  6
Constipation * 1  2/6 (33.33%)  6
Diarrhea * 1  2/6 (33.33%)  6
Anal incontinence * 1  1/6 (16.67%)  6
Oral dysaesthesia * 1  1/6 (16.67%)  6
Stomatitis * 1  1/6 (16.67%)  6
Vomiting * 1  1/6 (16.67%)  6
General disorders   
Fatigue * 1  3/6 (50.00%)  6
Pyrexia * 1  2/6 (33.33%)  6
Chills * 1  1/6 (16.67%)  6
Facial Pain * 1  1/6 (16.67%)  6
Malaise * 1  1/6 (16.67%)  6
Edema * 1  1/6 (16.67%)  6
Immune system disorders   
Conjunctivitis * 1  1/6 (16.67%)  6
Hypersensitivity * 1  1/6 (16.67%)  6
Infections and infestations   
Mucosal infection * 1  1/6 (16.67%)  6
Urinary tract infection * 1  1/6 (16.67%)  6
Vulvovaginal candidiasis * 1  1/6 (16.67%)  6
Injury, poisoning and procedural complications   
Infusion related reaction * 1  1/6 (16.67%)  6
Investigations   
White blood cell count decreased * 1  6/6 (100.00%)  6
Neutrophil count decreased * 1  5/6 (83.33%)  6
Alanine aminotransferase increased * 1  1/6 (16.67%)  6
Asparate aminotransferase increased * 1  1/6 (16.67%)  6
Blood alkaline phosphatase increased * 1  1/6 (16.67%)  6
Blood creatinine increased * 1  1/6 (16.67%)  6
Serum ferritin increased * 1  1/6 (16.67%)  6
Troponin increased * 1  1/6 (16.67%)  6
Metabolism and nutrition disorders   
Decreased appetite * 1  3/6 (50.00%)  6
Hyperglycemia * 1  1/6 (16.67%)  6
Hypernatremia * 1  1/6 (16.67%)  6
Hypokalemia * 1  1/6 (16.67%)  6
Hypomagnesemia * 1  1/6 (16.67%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/6 (16.67%)  6
Back Pain * 1  1/6 (16.67%)  6
Bone Pain * 1  1/6 (16.67%)  6
Muscular weakness * 1  1/6 (16.67%)  6
Musculoskeletal chest pain * 1  1/6 (16.67%)  6
Myalgia * 1  1/6 (16.67%)  6
Nervous system disorders   
Headache * 1  2/6 (33.33%)  6
Dizziness * 1  1/6 (16.67%)  6
Presyncope * 1  1/6 (16.67%)  6
Psychiatric disorders   
Confusional state * 1  2/6 (33.33%)  6
Anxiety * 1  1/6 (16.67%)  6
Renal and urinary disorders   
Proteinuria * 1  1/6 (16.67%)  6
Renal failure * 1  1/6 (16.67%)  6
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  2/6 (33.33%)  6
Nasal Congestion * 1  2/6 (33.33%)  6
Cough * 1  1/6 (16.67%)  6
Oropharyngeal pain * 1  1/6 (16.67%)  6
Pleural effusion * 1  1/6 (16.67%)  6
Upper airway cough syndrome * 1  1/6 (16.67%)  6
Wheezing * 1  1/6 (16.67%)  6
Skin and subcutaneous tissue disorders   
Dry Skin * 1  3/6 (50.00%)  6
Alopecia * 1  2/6 (33.33%)  6
Rash * 1  2/6 (33.33%)  6
Dermatitis allergic * 1  1/6 (16.67%)  6
Pruritus * 1  1/6 (16.67%)  6
Vascular disorders   
Hypotension * 1  1/6 (16.67%)  6
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
Phone: 215-825-9302 ext 6302
Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT01567891     History of Changes
Other Study ID Numbers: ADP-0011-001
230612 ( Other Identifier: Adaptimmune )
First Submitted: March 16, 2012
First Posted: March 30, 2012
Results First Submitted: July 13, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019