Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236139
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-01-09
Brief Title:
Cell Therapy STEAP1 CART With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase 12 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial tests the safety and effectiveness of cell therapy STEAP1 CART with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production castration-resistant and that has spread from where it first started the prostate to other places in the body metastatic Prostate cancer is the second leading cause of cancer deaths in men Localized prostate cancer is often curable and even metastatic disease may respond to treatment for a few years Despite multiple therapies including hormone therapy and chemotherapy metastatic castration-resistant prostate cancer mCRPC still remains an incurable disease Recently adoptive cellular immunotherapies have been developed to transfer immunogenic cells to the patient to produce an anti-tumor response Chimeric antigen receptor T CART-cell therapy is a type of treatment in which a patients T-cells a type of immune cell are changed in the laboratory so they will attack tumor cells T cells are taken from a patients blood Then the gene for a special receptor that binds to a certain protein on the patients tumor cells is added to the T cells in the laboratory The special receptor is called a chimeric antigen receptor CAR Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers Prostate stem cell antigen and prostate specific membrane antigen CAR T cell therapies have been shown to be safe and effective but objective tumor responses remain rare STEAP1 is an antigen that promotes cancer growth and spread and is found to be broadly expressed in mCRPC tissues STEAP1 CART is CAR T cells that have been engineered with a STEAP1 antigen to better target prostate tumor cells Enzalutamide is in a class of medications called androgen receptor inhibitors It works by blocking the effects of androgen a male reproductive hormone to stop the growth and spread of cancer cells Giving STEAP1 CART with enzalutamide may kill more tumor cells in patients with mCRPC
Detailed Description:
OUTLINE This is a dose escalation study of STEAP1 CART in combination with enzalutamide followed by a dose expansion study
Patients undergo leukapheresis then receive cyclophosphamide intravenously IV and fludarabine IV on days -5 -4 and -3 and STEAP1 CART IV on day 0 Patients may receive enzalutamide orally PO on day 0 then once daily QD in the absence of disease progression or unacceptable toxicity Patients also undergo a tumor biopsy at baseline day 14 and optionally at progression Patients additionally undergo blood sample collection nuclear medicine NM bone scan and computed tomography CT scan or magnetic resonance imaging MRI or positron emission tomography PET scan throughout study Additionally patients may undergo echocardiography ECHO or multigated acquisition scan MUGA at screening
After completion of study treatment patients are followed up at 2 3 4 5 6 9 and 12 months then every 6 months up to year 5 followed by yearly up to year 15
Patients undergo leukapheresis then receive cyclophosphamide intravenously IV and fludarabine IV on days -5 -4 and -3 and STEAP1 CART IV on day 0 Patients may receive enzalutamide orally PO on day 0 then once daily QD in the absence of disease progression or unacceptable toxicity Patients also undergo a tumor biopsy at baseline day 14 and optionally at progression Patients additionally undergo blood sample collection nuclear medicine NM bone scan and computed tomography CT scan or magnetic resonance imaging MRI or positron emission tomography PET scan throughout study Additionally patients may undergo echocardiography ECHO or multigated acquisition scan MUGA at screening
After completion of study treatment patients are followed up at 2 3 4 5 6 9 and 12 months then every 6 months up to year 5 followed by yearly up to year 15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20204 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |
| NCI-2023-10316 | REGISTRY | None | None |