Trial Outcomes & Findings for CT Antigen TCR-Engineered T Cells for Myeloma (NCT NCT01892293)
NCT ID: NCT01892293
Last Updated: 2019-01-10
Results Overview
Number of Participants with NCI CTCAE Version 4.0 Adverse Events related to study treatment greater than or equal to Grade 3
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2019-01-10
Participant Flow
Participant milestones
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
Received T-cell
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Overall Study
Apheresed but not treated
|
4
|
Baseline Characteristics
CT Antigen TCR-Engineered T Cells for Myeloma
Baseline characteristics by cohort
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
n=2 Participants
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
64.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who received NY-ESO-1ᶜ²⁵⁹T
Number of Participants with NCI CTCAE Version 4.0 Adverse Events related to study treatment greater than or equal to Grade 3
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
n=2 Participants
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Adverse Events Related to Study Treatment
|
2 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Participants who received NY-ESO-1ᶜ²⁵⁹T
Number of participants with response post-infusion as assessed by international uniform response criteria
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
n=2 Participants
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Evaluate the Direct Anti-tumor Activity of NY-ESO-1ᶜ²⁵⁹T
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 15, 22, 29, 43, 101, 130 181, every 3 months thereafterPopulation: Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with persistence data
Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
n=2 Participants
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Peak Persistence of Modified T-cells in the Peripheral Blood
|
29,179 copies per μg of DNA
Interval 4479.0 to
|
Adverse Events
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
n=2 participants at risk
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Injury, poisoning and procedural complications
Humerus fracture
|
50.0%
1/2 • Number of events 2 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Other adverse events
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
n=2 participants at risk
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
|
|---|---|
|
Investigations
White blood cell count decreased
|
100.0%
2/2 • Number of events 2 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 2 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Neutrophil count decreased
|
100.0%
2/2 • Number of events 2 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Cardiac disorders
Sinus bradycardia
|
50.0%
1/2 • Number of events 1 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60