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The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101.
Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMARTâ„¢ designed IL-2 cytokine in platinum-resistant ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPB-101 Treatment Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPB-101 | Biological | An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Incidence of dose-limiting toxicities (DLTs) | 28 days |
| Safety | Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths | 2 years |
| Safety | To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s) | 2 years |
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Inclusion Criteria:
Note: Other protocol defined inclusion criteria could apply
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Ferraro, MBA | Contact | 3039290208 | clinicaltrials@outpacebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Roswell Park | Recruiting | Buffalo | New York | 14203 | United States |
|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |