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Trial record 1 of 12 for:    ct antigen myeloma
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CT Antigen TCR-Engineered T Cells for Myeloma

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ClinicalTrials.gov Identifier: NCT01892293
Recruitment Status : Terminated (Sponsor Decision)
First Posted : July 4, 2013
Results First Posted : July 24, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: Treatment with NY-ESO-1c259-modified T cells
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
Period Title: Overall Study
Started 6
Received T-cell 2
Completed 2
Not Completed 4
Reason Not Completed
Apheresed but not treated             4
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
Participants who received NY-ESO-1ᶜ²⁵⁹T
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
64.5
(61 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 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
2
 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 CTCAE Version 4.0 Adverse Events related to study treatment greater than or equal to Grade 3
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NY-ESO-1ᶜ²⁵⁹T
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
2.Secondary Outcome
Title Evaluate the Direct Anti-tumor Activity of NY-ESO-1ᶜ²⁵⁹T
Hide Description Number of participants with response post-infusion as assessed by international uniform response criteria
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NY-ESO-1ᶜ²⁵⁹T
Arm/Group Title NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
Overall Number of Participants Analyzed 2
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 (copies of WPRE per µg of genomic PBMC DNA)
Time Frame Days 1, 3, 5, 8, 15, 22, 29, 43, 101, 130 181, every 3 months thereafter
Hide 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 NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Hide Arm/Group Description:
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: copies per μg of DNA
29,179
(4479 to 53,879)
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 Cells Administered IV
Hide Arm/Group Description Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
All-Cause Mortality
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Affected / at Risk (%)
Total   2/2 (100.00%)    
Hide Serious Adverse Events
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Injury, poisoning and procedural complications   
Humerus fracture * 1  1/2 (50.00%)  2
1
Term from vocabulary, MedDRA version 18
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  1/2 (50.00%)  1
Cardiac disorders   
Sinus bradycardia * 1  1/2 (50.00%)  1
General disorders   
Fatigue * 1  1/2 (50.00%)  1
Investigations   
White blood cell count decreased * 1  2/2 (100.00%)  2
Lymphocyte count decreased * 1  2/2 (100.00%)  2
Neutrophil count decreased * 1  2/2 (100.00%)  2
Aspartate aminotransferase increased * 1  1/2 (50.00%)  1
Metabolism and nutrition disorders   
Hypercalcemia * 1  1/2 (50.00%)  1
Hypertriglyceridemia * 1  1/2 (50.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign neoplasm * 1  1/2 (50.00%)  1
Vascular disorders   
Hypertension * 1  1/2 (50.00%)  1
1
Term from vocabulary, MedDRA (18.0)
*
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Management
Organization: Adaptimmune
EMail: clinicaltrials@adaptimmune.com
Layout table for additonal information
Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT01892293    
Other Study ID Numbers: ADP-0011-002
First Submitted: June 27, 2013
First Posted: July 4, 2013
Results First Submitted: March 20, 2018
Results First Posted: July 24, 2018
Last Update Posted: January 10, 2019