Trials / Active Not Recruiting
Active Not RecruitingNCT03907527
Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Phase I/Ib Study Evaluating Safety and Efficacy of PRGN-3005 UltraCAR-T® (Autologous CAR T Cells) in Advanced Stage Platinum Resistant Ovarian Cancer Patients
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 71 (estimated)
- Sponsor
- Precigen, Inc · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I/Ib dose escalation, dose expansion, study to evaluate the safety and identify the recommended dose of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc.) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.
Conditions
- Platinum-Resistant Fallopian Tube Carcinoma
- Platinum-Resistant Ovarian Carcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Refractory Fallopian Tube Carcinoma
- Refractory Ovarian Carcinoma
- Refractory Primary Peritoneal Carcinoma
- Stage III Fallopian Tube Cancer AJCC V8
- Stage III Ovarian Cancer AJCC V8
- Stage III Primary Peritoneal Cancer AJCC V8
- Stage IIIA Fallopian Tube Cancer AJCC V8
- Stage IIIA Ovarian Cancer AJCC V8
- Stage IIIA Primary Peritoneal Cancer AJCC V8
- Stage IIIA1 Fallopian Tube Cancer AJCC V8
- Stage IIIA1 Ovarian Cancer AJCC V8
- Stage IIIA2 Fallopian Tube Cancer AJCC V8
- Stage IIIA2 Ovarian Cancer AJCC V8
- Stage IIIB Fallopian Tube Cancer AJCC V8
- Stage IIIB Ovarian Cancer AJCC V8
- Stage IIIB Primary Peritoneal Cancer AJCC V8
- Stage IIIC Fallopian Tube Cancer AJCC V8
- Stage IIIC Ovarian Cancer AJCC V8
- Stage IIIC Primary Peritoneal Cancer AJCC V8
- Stage IV Fallopian Tube Cancer AJCC V8
- Stage IV Ovarian Cancer AJCC V8
- Stage IV Primary Peritoneal Cancer AJCC V8
- Stage IVA Fallopian Tube Cancer AJCC V8
- Stage IVA Ovarian Cancer AJCC V8
- Stage IVA Primary Peritoneal Cancer AJCC V8
- Stage IVB Fallopian Tube Cancer AJCC V8
- Stage IVB Ovarian Cancer AJCC V8
- Stage IVB Primary Peritoneal Cancer AJCC V8
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PRGN-3005 UltraCAR-T cells | Given IP |
| BIOLOGICAL | PRGN-3005 UltraCAR-T cells | Given IV |
Timeline
- Start date
- 2019-04-30
- Primary completion
- 2024-12-15
- Completion
- 2028-11-15
- First posted
- 2019-04-09
- Last updated
- 2024-11-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03907527. Inclusion in this directory is not an endorsement.