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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
Phase 1, PHASE2 trial testing Atezolizumab in Anatomic Stage IV Breast Cancer AJCC v8 in 1 participant. Terminated before completion.
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 19 July 2021 |
| Primary completion | 4 August 2022 |
| Estimated completion | 16 August 2022 |
| Sites | 1 location across United States |
Fred Hutchinson Cancer Center — full company profile →
18 and older, any sex, with Anatomic Stage IV Breast Cancer AJCC v8 or Metastatic Lung Non-Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Lesions 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 disea
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 | |
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 | |
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 1 | |
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Results 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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0101 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0303 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0379 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0379 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0111 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0087 |
Outcome 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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Outcome 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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Outcome will be reported as a count of participants that were alive at the 1 year post infusion timepoint.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Evaluated 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
| Group | Value | 95% CI |
|---|---|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Time frame: Up to 4 weeks following the last infusion per patient.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (FH-MagIC TCR-T … |
|---|---|---|
| Bloating | Gastrointestinal disorders | — |
| Concentration impairment | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Edema limbs | General disorders | — |
| Fatigue | General disorders | — |
| Hyperphosphatemia | General disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — |
| COVID-19 | Infections and infestations | — |
| Insomnia | Psychiatric disorders | — |
| Lung infection | Infections and infestations | — |
| Non-cardiac chest pain | General disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Deep Vein Thrombosis | Vascular disorders | — |
| Pulmonary Embolism | Vascular disorders | — |
Data from ClinicalTrials.gov NCT04639245 adverse events section.
This phase I/II trial investigates the side effects of genetically engineered cells called FH-MagIC TCR-T cells and how well they work with atezolizumab in treating patients with triple negative breast cancer, urothelial cancer, or non-small cell lung cancer that has spread to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize MAGE-A1, a protein on the surface of tumor cells. These MAGE-A1-specific T cells may help the body's immune system identify and kill MAGE-A1 tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving FH-MagIC TCR-T cells with atezolizumab may help treat patients with triple negative breast cancer, urothelial cancer, or non-small cell lung cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04639245.
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