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Platinum-Resistant Fallopian Tube CarcinomaPhase 1NCT03907527

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

A Phase 1 study testing PRGN-3005 UltraCAR-T cells in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by Precigen, Inc at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
PRGN-3005 UltraCAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
2 sitesUnited States
Study dates
30 Apr 2019to 15 Nov 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • National Institutes of Health (NIH)

    Bethesda, Maryland, 20892

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Being tested
PRGN-3005 UltraCAR-T cells
Keywords
Platinum resistant, Ovarian Cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRGN-3005 UltraCAR-T cellsBiological

    Given IP

  • PRGN-3005 UltraCAR-T cellsBiological

    Given IV

Study groups in NCT03907527
Study groupRoleWhat they receive
Treatment (PRGN-3005 UltraCAR-T cells) IP AdministrationExperimentalPatients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.
Receives: Biological: PRGN-3005 UltraCAR-T cells
Treatment (PRGN-3005 UltraCAR-T cells) IV AdministrationExperimentalPatients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.
Receives: Biological: PRGN-3005 UltraCAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 12 months after infusion

  2. 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.

    Measured: Up to 28 days

Secondary outcomes (2)

  1. Evidence of anti-tumor activity

    Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    Measured: Up to 5 years

  2. Number of PRGN-3005 T Cells

    Number of PRGN-3005 T Cells present in patients treated with PRGN-3005

    Measured: Up to 12 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2019
  2. Study start30 Apr 2019
  3. Primary completion15 Dec 2024 (estimated)
  4. Study completion15 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03907527
Sponsor's protocol ID
RG1004303
Status last verified
Nov 2024
First submitted
5 Apr 2019
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRGN-3005 UltraCAR-T cells in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by Precigen, Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 12 months after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03907527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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