Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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

BIOLOGICAL

PRGN-3005 UltraCAR-T cells

Given IP

BIOLOGICAL

PRGN-3005 UltraCAR-T cells

Given IV

Sponsors & Collaborators

• Precigen, Inc

  lead INDUSTRY

Principal Investigators

• Amy R. Lankford, PhD · Precigen, Inc

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-30

Primary Completion

2024-12-15

Completion

2028-11-15

FDA Drug

Yes

Countries

• United States

Study Locations