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

Primary Purpose

Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRGN-3005 UltraCAR-T cells
PRGN-3005 UltraCAR-T cells
Sponsored by
Precigen, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum-Resistant Fallopian Tube Carcinoma focused on measuring Platinum resistant, Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that have progressed after receiving standard of care therapies or are not eligible to receive available therapies with known clinical benefit will be eligible for the study. Patients must have measurable disease that can be accurately measured by RECIST 1.1 criteria in at least one dimension as >= 1.0 cm or > 1.5 cm lymph node with computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI) techniques.

    • Platinum resistant is defined as progression of disease within six months of platinum regimen.
    • Patients with BRCA mutations who have completed standard therapies (including PARP inhibitors) are allowed on this study.
  • Patients must be capable of understanding and providing a written informed consent.
  • Patients must be 14 days from previous cytotoxic chemotherapy at time of cell collection.
  • Laboratory values must indicate adequate organ function.
  • Patients must be at least 28 days post systemic steroids prior to enrollment except as premedication for contrast allergy and/or other protocol-mandated medication.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2.
  • Patients must have recovered from major acute infections and/or recent surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment.
  • Negative pregnancy test for women of childbearing potential. Women of childbearing potential are those who have not been surgically sterilized, are < 60 years old, or have had menses within the past 12 months.
  • Women of childbearing potential must be willing to use 2 methods of contraception before, during, and at least 4 months after the PRGN-3005 cell infusion.

Exclusion Criteria:

  • Patients with any of the following cardiac conditions:

    • Symptomatic restrictive cardiomyopathy
    • Unstable angina or symptomatic coronary artery disease within 4 months prior to enrollment
    • New York Heart Association functional class III-IV heart failure on active treatment
    • Symptomatic pericardial effusion
    • Congestive heart failure
    • Clinically significant hypotension.
  • Patients with CA 125 =< ULN during screening.
  • Patients with history of human immunodeficiency virus (HIV), West Nile, Zika, or active hepatitis B or C infections.
  • Patients with severe, symptomatic ascites requiring diuretics, regular paracentesis, or other invasive interventions.
  • Patients within 28 days of receiving another investigational agent.
  • Patients with pulmonary hypertension, pulmonary fibrosis, or restrictive lung disease, patients with baseline oxygen saturation on room air < 92%, forced expiratory volume in 1 second (FEV1) =< 50%, or diffusion capacity of the lung for carbon monoxide (DLco) (corrected) of < 40% will be excluded.
  • Women who are pregnant or breast feeding.
  • Patients with second malignancy within the last 5 years excluding basal carcinoma of the skin, squamous carcinoma of the skin, or in situ cervical dysplasia that has undergone curative therapy.
  • Patients with an active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.
  • Patients who are simultaneously enrolled in any other treatment study.
  • Clinical or radiological evidence of acute bowel obstruction within 30 days of signing consent.
  • Patients with known or treated brain metastases.
  • Patients with an active seizure disorder.
  • Any female patient <60 years old who does not meet at least one of the following criteria will be considered to have reproductive potential:

    • Post-menopausal for at least 12 consecutive months (i.e., no menses), or
    • Undergone a sterilization procedure (hysterectomy, salpingectomy, or bilateral oophorectomy; tubal ligation is not considered a sterilization procedure). Pregnancy test for females of reproductive potential must be negative within 14 days before leukapheresis.

Sites / Locations

  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment (PRGN-3005 UltraCAR-T cells) IP Administration

Treatment (PRGN-3005 UltraCAR-T cells) IV Administration

Arm Description

Patients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.

Patients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.

Outcomes

Primary Outcome Measures

Incidence of adverse events
Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events
Maximal tolerated dose of PRGN-3005
Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.

Secondary Outcome Measures

Evidence of anti-tumor activity
Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Number of PRGN-3005 T Cells
Number of PRGN-3005 T Cells present in patients treated with PRGN-3005

Full Information

First Posted
April 5, 2019
Last Updated
January 5, 2023
Sponsor
Precigen, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03907527
Brief Title
Modified Immune Cells (Autologous CAR T Cells) in Treating Patients With Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
November 15, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Precigen, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Platinum resistant, Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (PRGN-3005 UltraCAR-T cells) IP Administration
Arm Type
Experimental
Arm Description
Patients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.
Arm Title
Treatment (PRGN-3005 UltraCAR-T cells) IV Administration
Arm Type
Experimental
Arm Description
Patients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.
Intervention Type
Biological
Intervention Name(s)
PRGN-3005 UltraCAR-T cells
Intervention Description
Given IP
Intervention Type
Biological
Intervention Name(s)
PRGN-3005 UltraCAR-T cells
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events
Time Frame
Up to 12 months after infusion
Title
Maximal tolerated dose of PRGN-3005
Description
Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Evidence of anti-tumor activity
Description
Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time Frame
Up to 5 years
Title
Number of PRGN-3005 T Cells
Description
Number of PRGN-3005 T Cells present in patients treated with PRGN-3005
Time Frame
Up to 12 months post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that have progressed after receiving standard of care therapies or are not eligible to receive available therapies with known clinical benefit will be eligible for the study. Patients must have measurable disease that can be accurately measured by RECIST 1.1 criteria in at least one dimension as >= 1.0 cm or > 1.5 cm lymph node with computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI) techniques. Platinum resistant is defined as progression of disease within six months of platinum regimen. Patients with BRCA mutations who have completed standard therapies (including PARP inhibitors) are allowed on this study. Patients must be capable of understanding and providing a written informed consent. Patients must be 14 days from previous cytotoxic chemotherapy at time of cell collection. Laboratory values must indicate adequate organ function. Patients must be at least 28 days post systemic steroids prior to enrollment except as premedication for contrast allergy and/or other protocol-mandated medication. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2. Patients must have recovered from major acute infections and/or recent surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment. Negative pregnancy test for women of childbearing potential. Women of childbearing potential are those who have not been surgically sterilized, are < 60 years old, or have had menses within the past 12 months. Women of childbearing potential must be willing to use 2 methods of contraception before, during, and at least 4 months after the PRGN-3005 cell infusion. Exclusion Criteria: Patients with any of the following cardiac conditions: Symptomatic restrictive cardiomyopathy Unstable angina or symptomatic coronary artery disease within 4 months prior to enrollment New York Heart Association functional class III-IV heart failure on active treatment Symptomatic pericardial effusion Congestive heart failure Clinically significant hypotension. Patients with CA 125 =< ULN during screening. Patients with history of human immunodeficiency virus (HIV), West Nile, Zika, or active hepatitis B or C infections. Patients with severe, symptomatic ascites requiring diuretics, regular paracentesis, or other invasive interventions. Patients within 28 days of receiving another investigational agent. Patients with pulmonary hypertension, pulmonary fibrosis, or restrictive lung disease, patients with baseline oxygen saturation on room air < 92%, forced expiratory volume in 1 second (FEV1) =< 50%, or diffusion capacity of the lung for carbon monoxide (DLco) (corrected) of < 40% will be excluded. Women who are pregnant or breast feeding. Patients with second malignancy within the last 5 years excluding basal carcinoma of the skin, squamous carcinoma of the skin, or in situ cervical dysplasia that has undergone curative therapy. Patients with an active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment. Patients who are simultaneously enrolled in any other treatment study. Clinical or radiological evidence of acute bowel obstruction within 30 days of signing consent. Patients with known or treated brain metastases. Patients with an active seizure disorder. Any female patient <60 years old who does not meet at least one of the following criteria will be considered to have reproductive potential: Post-menopausal for at least 12 consecutive months (i.e., no menses), or Undergone a sterilization procedure (hysterectomy, salpingectomy, or bilateral oophorectomy; tubal ligation is not considered a sterilization procedure). Pregnancy test for females of reproductive potential must be negative within 14 days before leukapheresis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy R. Lankford, PhD
Phone
301-556-9900
Email
clinicaltrials@precigen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy R. Lankford, PhD
Organizational Affiliation
Precigen, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IMTX Intake Coordinator
Phone
866-268-6129
Email
immunotherapy@seattlecca.org
First Name & Middle Initial & Last Name & Degree
John Liao

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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