CLINICAL TRIAL

PRGN-3005 UltraCAR-T cells for Peritoneal Neoplasms

Recruiting · 18+ · Female · Seattle, WA

This study is evaluating whether a new type of immune cell may help treat cancer.

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About the trial for Peritoneal Neoplasms

Eligible Conditions
Stage IIIA1 Fallopian Tube Cancer AJCC v8 · Recurrent Primary Peritoneal Carcinoma · Platinum-Resistant Fallopian Tube Carcinoma · Stage IIIA Fallopian Tube Cancer AJCC v8 · Stage III Fallopian Tube Cancer AJCC v8 · Fallopian Tube Neoplasms · Stage IV Primary Peritoneal Cancer AJCC v8 · Recurrent Fallopian Tube Carcinoma · Stage IVB Primary Peritoneal Cancer AJCC v8 · Platinum-Resistant Primary Peritoneal Carcinoma · Recurrent Ovarian Carcinoma · Stage IIIB Fallopian Tube Cancer AJCC v8 · Stage IVB Fallopian Tube Cancer AJCC v8 · Stage IVA Fallopian Tube Cancer AJCC v8 · Stage IIIA Primary Peritoneal Cancer AJCC v8 · Stage IVA Primary Peritoneal Cancer AJCC v8 · Peritoneal Neoplasms · Platinum-Resistant Ovarian Carcinoma · Stage IIIA1 Ovarian Cancer AJCC v8 · Stage IIIB Primary Peritoneal Cancer AJCC v8 · Stage IVA Ovarian Cancer AJCC v8 · Stage IIIB Ovarian Cancer AJCC v8 · Stage IIIC Primary Peritoneal Cancer AJCC v8 · Stage IV Ovarian Cancer AJCC v8 · Stage IIIC Ovarian Cancer AJCC v8 · Stage IIIC Fallopian Tube Cancer AJCC v8 · Stage IVB Ovarian Cancer AJCC v8 · Carcinoma, Ovarian Epithelial · Stage III Ovarian Cancer AJCC v8 · Stage IV Fallopian Tube Cancer AJCC v8 · Carcinoma · Stage III Primary Peritoneal Cancer AJCC v8 · Stage IIIA Ovarian Cancer AJCC v8 · Refractory Fallopian Tube Carcinoma · Stage IIIA2 Ovarian Cancer AJCC v8 · Refractory Ovarian Carcinoma · Refractory Primary Peritoneal Carcinoma · Ovarian Neoplasms · Stage IIIA2 Fallopian Tube Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. PRGN-3005 UltraCAR-T Cells is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
PRGN-3005 UltraCAR-T cells
BIOLOGICAL
Experimental Group 2
PRGN-3005 UltraCAR-T cells
BIOLOGICAL

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Peritoneal Neoplasms or one of the other 38 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2.
Patients must be at least 28 days post systemic steroids prior to enrollment except as premedication for contrast allergy.
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether PRGN-3005 UltraCAR-T cells will improve 2 primary outcomes and 1 secondary outcome in patients with Peritoneal Neoplasms. Measurement will happen over the course of Up to 28 days.

Maximal tolerated dose of PRGN-3005
UP TO 28 DAYS
Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.
Incidence of adverse events
UP TO 12 MONTHS AFTER INFUSION
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
Evidence of anti-tumor activity
UP TO 5 YEARS
Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get peritoneal neoplasms a year in the United States?

Approximately 21,080 peritoneal neoplasms per year are diagnosed in the United States. Peritoneal neoplasms are rarer in patients younger than 45 years. The increased use of medical imaging in this patient population makes the possibility that they are false-negative for peritoneal neoplasms more likely than in older patients.

Anonymous Patient Answer

What is peritoneal neoplasms?

Peritoneal neoplasms are solid/loose lesions or malignant lesions that are seen in the gastrointestinal wall of the abdomen or adjacent organs. Peritonitis is a clinical condition that occurs when peritoneal fluid or a gas-fluid interface in the abdominal cavity becomes infected and the lining fluid and other secretions of the peritoneum becomes pus-like.

Anonymous Patient Answer

What are the signs of peritoneal neoplasms?

The signs of peritoneal neoplasms include: a history of peritoneal fluid or blood, ascites, abdominal and [back pain](https://www.withpower.com/clinical-trials/back-pain), an epigastric mass, abdominal wall herniation, pain with coughing.

Anonymous Patient Answer

What causes peritoneal neoplasms?

A range of environmental risk factors can be associated with peritoneal tumorigenesis. The aetiology of mesotheliomas is mainly related to asbestos exposure. Fibrous tumors of the peritoneum are primarily caused by chronic, local exposure to carcinomatous or chondromatous substances.

Anonymous Patient Answer

Can peritoneal neoplasms be cured?

When cure is the objective, a complete surgical resection (surgical complete remission) can be attempted. In patients who undergo the complete removal of the neoplasm and are subjected to adjuvant chemotherapy, there is a higher chance of achieving long-term survival even when the tumour remains incompletely removed, if one exists.

Anonymous Patient Answer

What are common treatments for peritoneal neoplasms?

Treatment is aimed at complete surgical resection with the goal of achieving complete remission. Palliative surgery is also performed. Peritoneal nodular or cystic neoplasms may resolve or remain stable, but recurrence may still be expected. Primary treatment comprises no treatment or observation.

Anonymous Patient Answer

Has prgn-3005 ultracar-t cells proven to be more effective than a placebo?

Results from a recent clinical trial of this study suggest that prgn-3005 is safe and effective in alleviating disease severity at 3 and 24 weeks of treatment. These data support the conclusion that prgn-3005 may be a novel and therapeutically effective agent in treating patients with advanced peritoneal sarcoma.

Anonymous Patient Answer

Have there been other clinical trials involving prgn-3005 ultracar-t cells?

Prim-GN3005 does not seem to be more effective than prgn-1002 alone in treating peritoneal metastases from advanced carcinoma of the gastrointestinal tract. Results from a recent paper need confirmation in larger, well-designed and blinded studies.

Anonymous Patient Answer

What are the latest developments in prgn-3005 ultracar-t cells for therapeutic use?

Ultracar-t cells can form large colonies and differentiate in culture into cells with the in vitro characteristics of myeloid cells and neuroendocrine cells. A significant decrease in growth of intratumoral tumor has been observed in all test models.

Anonymous Patient Answer

How serious can peritoneal neoplasms be?

Given the risk of peritoneal complications, we think laparoscopic resection is preferable whenever possible. Radical abdominal operations are still necessary in the event of inoperable local recurrences. In these patients, adjuvant chemotherapy is still recommended.

Anonymous Patient Answer

What are the chances of developing peritoneal neoplasms?

While some people will develop a peritoneal neoplasm, the prevalence of peritoneal neoplasms seems to be 1 to 4 cases/1,000 people per year. People at high risk of developing peritoneal malignancies should have a high index of suspicion and prompt referral for evaluation. The most commons presenting symptom is an abdominal mass or abdominal discomfort, but peritoneal malignancies can present with a wide variety of symptoms and signs as they often cause significant disruption of the visceral organs, which cause abdominal pain. The majority of them are discovered incidentally, although the presence of metastasis to the liver is the only significant prognostic factor.

Anonymous Patient Answer

How quickly does peritoneal neoplasms spread?

The survival of patients with malignant peritoneal neoplasms does not appear to be related to the size of the primary tumor. This fact is suggestive of an independent role of liver involvement and/or the presence of nodules in metastatic dissemination.

Anonymous Patient Answer
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