Trial Outcomes & Findings for MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes (NCT NCT01273181)
NCT ID: NCT01273181
Last Updated: 2015-10-28
Results Overview
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
2 years
Results posted on
2015-10-28
Participant Flow
Ph I:study will begin by evaluating the safety of 2 ranges of cells,5x10\^9-3x10\^10, \& \>3x10\^10-1x10\^11 in a standard ph I dose escalation using a 3+3 design. Ph II:pts will be entered into 2 cohorts based on histology:cohort 1 will include pts with metastatic melanoma or RCC; cohort 2 will include pts with other types of metastatic cancer.
Participant milestones
| Measure |
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
|
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
|
|---|---|---|---|---|
|
Phase I, Dose 1
STARTED
|
3
|
0
|
0
|
0
|
|
Phase I, Dose 1
COMPLETED
|
2
|
0
|
0
|
0
|
|
Phase I, Dose 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Phase I, Dose 2
STARTED
|
0
|
3
|
0
|
0
|
|
Phase I, Dose 2
COMPLETED
|
0
|
2
|
0
|
0
|
|
Phase I, Dose 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Phase 2, Dose 1
STARTED
|
0
|
0
|
2
|
0
|
|
Phase 2, Dose 1
COMPLETED
|
0
|
0
|
1
|
0
|
|
Phase 2, Dose 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Phase 2, Dose 2
STARTED
|
0
|
0
|
0
|
1
|
|
Phase 2, Dose 2
COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2, Dose 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
|
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
|
|---|---|---|---|---|
|
Phase I, Dose 1
Study termination
|
1
|
0
|
0
|
0
|
|
Phase I, Dose 2
Death during treatment
|
0
|
1
|
0
|
0
|
|
Phase 2, Dose 1
Study termination
|
0
|
0
|
1
|
0
|
|
Phase 2, Dose 2
Death during treatment
|
0
|
0
|
0
|
1
|
Baseline Characteristics
MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes
Baseline characteristics by cohort
| Measure |
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
n=3 Participants
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
n=3 Participants
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
n=2 Participants
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
n=1 Participants
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 16.9 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
71.0 years
n=4 Participants
|
51.9 years
STANDARD_DEVIATION 15.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
00 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
n=3 Participants
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
n=3 Participants
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
n=2 Participants
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
n=1 Participants
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
|---|---|---|---|---|
|
Toxicity Profile
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
n=3 Participants
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
n=3 Participants
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
n=2 Participants
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
n=1 Participants
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
|---|---|---|---|---|
|
Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer
Complete Response
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer
Partial Response
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
n=3 participants at risk
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
n=3 participants at risk
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
n=2 participants at risk
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
n=1 participants at risk
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
ALT/SGPT (serum glutamic pyruvic transaminase)
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
AST/SGOT (serum glutamic oxaloacetic transaminase)
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Amylase
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Speech impairment (e.g. dysphasia or aphasia)
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
Other adverse events
| Measure |
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9
n=3 participants at risk
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10
n=3 participants at risk
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
n=2 participants at risk
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
n=1 participants at risk
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Infections and infestations
Febrile neutropenia
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Lipase
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
100.0%
3/3 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Nervous system disorders
Confusion
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
Vascular disorders
Acute vascular leak syndrome
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
|
Cardiac disorders
Supraventricular & nodal arrhythmia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
PTT (partial thromboplastin time)
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
General disorders
Pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
Additional Information
Dr. Steven Rosenberg
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place