Trial Outcomes & Findings for Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer (NCT NCT04639245)
NCT ID: NCT04639245
Last Updated: 2023-08-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
4 weeks post last infusion per patient
Results posted on
2023-08-03
Participant Flow
Participant milestones
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
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
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post last infusion per patientOutcome measures
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Count of Participants That Experienced Treatment-related Unexpected Grade 3 or Higher Adverse Events
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 year post infusionLesions will be separately tracked but response determined in totality. As indicated, patient must have at least one trackable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response will be a defined as best overall response by RECIST 1.1. A Complete Response will be defined as total regression of all tumors, a Partial Response as 30% or greater decrease in the sum of the longest diameter of target lesions compared to baseline and Progressive Disease as 20% increase in the sum of the longest diameter of target lesions compared to the smallest prior diameter. If the disease does not fall in either category it will be considered Stable Disease (RECIST v1.1 criteria).
Outcome measures
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Best Overall Response
Complete response
|
0 Participants
|
|
Best Overall Response
Partial response
|
0 Participants
|
|
Best Overall Response
Stable disease
|
1 Participants
|
|
Best Overall Response
Progressive disease
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year post infusionResults will be reported by sample for the single treated patient. Patient samples were tested using a WPRE assay showing transgenic T cells in blood. This was detected by qPCR.
Outcome measures
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I2D28
|
0.0333 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712PRETX
|
0.0 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D000
|
0.0 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D001
|
0.0101 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D003
|
0.0303 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D007
|
0.0379 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D014
|
0.0379 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D021
|
0.0111 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D028
|
0.0087 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D056
|
0.0107 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I1D180
|
0.0062 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I2D03
|
0.1167 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I2D07
|
0.0795 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I2D14
|
0.0353 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I2D21
|
0.0267 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I2D56
|
0.0027 WPRE copies/Cell
|
|
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
BU712I2D84
|
0.0070 WPRE copies/Cell
|
SECONDARY outcome
Timeframe: 1 year post infusionOutcome will be reported as a count of participants that displayed transgenic T cells in their tumor tissue after treatment. This was assessed by WRPE staining and scRNA sequencing. Unfortunately, no transgenic cells were detected on the one treated patient's tumors.
Outcome measures
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Participants That Displayed Transgenic T Cells in Tumor Tissue
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year post infusionOutcome will be reported as a count of participants that were alive as the 1 year post infusion timepoint and also had not experienced progression at that timepoint.
Outcome measures
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Progression-free Survival
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year post infusionOutcome will be reported as a count of participants that were alive at the 1 year post infusion timepoint.
Outcome measures
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Overall Survival
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year post infusionEvaluated by immune-related RECIST criteria. Outcome will be reported as a count of participants that experienced a Complete Response or Partial Response per RECIST criteria. A complete response (CR) will be defined as total regression of all tumors, a Partial Response as 30% or greater decrease in the sum of the longest diameter of target lesions compared to baseline and Progressive Disease as 20% increase in the sum of the longest diameter of target lesions compared to the smallest prior diameter. If the disease does not fall in either category it will be considered Stable Disease (RECIST v1.1 criteria).
Outcome measures
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 Participants
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Objective Response Rates
|
0 Participants
|
Adverse Events
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (FH-MagIC TCR-T Cells, Atezolizumab)
n=1 participants at risk
LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.
T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.
In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Atezolizumab: Given IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells: Given IV
PD1 Inhibitor: Given IV
|
|---|---|
|
Gastrointestinal disorders
Bloating
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Nervous system disorders
Concentration impairment
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 3 • Up to 4 weeks following the last infusion per patient.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 2 • Up to 4 weeks following the last infusion per patient.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
General disorders
Edema limbs
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 2 • Up to 4 weeks following the last infusion per patient.
|
|
General disorders
Hyperphosphatemia
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 2 • Up to 4 weeks following the last infusion per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Number of events 3 • Up to 4 weeks following the last infusion per patient.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Infections and infestations
COVID-19
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Infections and infestations
Lung infection
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
General disorders
Non-cardiac chest pain
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • Number of events 3 • Up to 4 weeks following the last infusion per patient.
|
|
Vascular disorders
Deep Vein Thrombosis
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
|
Vascular disorders
Pulmonary Embolism
|
100.0%
1/1 • Number of events 1 • Up to 4 weeks following the last infusion per patient.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place