CLINICAL TRIAL

gavo-cel for Mesothelioma, Malignant

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Philadelphia, PA

Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

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About the trial for Mesothelioma, Malignant

Eligible Conditions
Ovarian Cancer · Lung Neoplasms · Non-Small Cell Lung Carcinoma (NSCLC) · Mesothelioma, Malignant · Mesothelioma; Peritoneum · Pleural Mesotheliomas · Cholangiocarcinoma · Pleura Mesothelioma · Carcinoma, Non-Small-Cell Lung · Recurrent Cholangiocarcinoma · Mesothelioma · Non Small Cell Lung Cancer Metastatic

Treatment Groups

This trial involves 3 different treatments. Gavo-cel is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
cyclophosphamide
DRUG
+
gavo-cel
DRUG
+
fludarabine
DRUG
Experimental Group 2
gavo-cel
DRUG
Experimental Group 3
cyclophosphamide
DRUG
+
gavo-cel
DRUG
+
fludarabine
DRUG
+
anti-PD1
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient is over 18 years old when they sign the informed consent. show original
Before getting the gavo-cel infusion, patients must have received at least one systemic standard of care therapy for metastatic or unresectable disease show original
The patient has a confirmed diagnosis of malignant pleural or peritoneal mesothelioma, serous ovarian adenocarcinoma, cholangiocarcinoma, or non-small cell lung cancer. show original
The patient's tumor has been found to express MSLN on more than 50% of the tumor cells and is positive for MSLN expression by immunohistochemistry. show original
The patient has a left ventricular ejection fraction of more than 45% as measured by a resting echocardiogram, and there is no clinically significant pericardial effusion. show original
The patient has a good prognosis and shouldn't have any problems completing treatment. show original
The patient is fit to have their white blood cells collected through a process called leukapheresis show original
A patient must have organ function that is acceptable by laboratory values in order to have the procedure done. show original
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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: Overall Response Rate at 3 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Overall Response Rate at 3 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Overall Response Rate at 3 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 gavo-cel will improve 2 primary outcomes in patients with Mesothelioma, Malignant. Measurement will happen over the course of DLTs within 28 days post-treatment.

Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
DLTS WITHIN 28 DAYS POST-TREATMENT
DLTS WITHIN 28 DAYS POST-TREATMENT
Phase 2 - To evaluate the efficacy of autologous genetically modified T cells (gavo-cel) in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate using RECIST v1.1
OVERALL RESPONSE RATE AT 3 MONTHS
OVERALL RESPONSE RATE AT 3 MONTHS

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 serious can mesothelioma, malignant be?

Mesothelioma is one of the most serious and potentially lethal thoracic malignancies. Survival in mesothelioma is exceedingly poor even relative to lung cancer and squamous cell carcinoma despite recent progress in the clinical treatment of primary mesothelioma. To improve survival, new treatment strategies are needed that focus on the suppression of the tumor immune system and/or enhancement of the antitumor immune response.

Anonymous Patient Answer

What are common treatments for mesothelioma, malignant?

There is no known cure for mesothelioma. Chemotherapy and concurrent radiotherapy may provide temporary relief from symptoms, which can improve quality of life. Surgery or radiotherapy of the pelvis and/or paraaortic lymph nodes is indicated in patients with peritoneal involvement, and in advanced cases, in the setting of progressive symptoms. However, there are no specific treatment guidelines specifically for mesothelioma due to the large amount of available information, with very individualized treatment regimens.

Anonymous Patient Answer

Can mesothelioma, malignant be cured?

No curative treatment for mesothelioma has yet been established. Patients who undergo curative surgery for the disease may have long-term survival, even when recurrent, and those who live the longest are those who have no relapse.

Anonymous Patient Answer

How many people get mesothelioma, malignant a year in the United States?

The annual incidence of malignant mesothelioma is very low: 1.4 per 10,000 people for both genders, with an annual incidence of about 1 case per million.

Anonymous Patient Answer

What is mesothelioma, malignant?

Mesothelioma is a cancer that forms in the serous fluid-producing lining of the tubes in the abdomen (peritoneal membrane) during the development of an infection. People with the condition may need surgery to remove the abnormal tissue. Mesothelioma is the most common cancer in the peritoneal cavity in women. The average survival time following diagnosis is 10 months.\n

Anonymous Patient Answer

What are the signs of mesothelioma, malignant?

The signs and symptoms of a malignant mesothelioma are similar to those of a malignant pleural disease (cancer of the pleura of the lung). They include cough, fever, weight loss and shortness of breath and depend on the stage of malignant mesothelioma. The symptoms can resemble those of other malignancies. To distinguish between malignant mesothelioma and other pulmonary conditions, a radiological examination, CT scan or PET scan is recommended. When the results are equivocal, biopsy is recommended. The treatment of malignant mesothelioma is dependent upon the stage of the disease and the patient's prognosis.

Anonymous Patient Answer

What causes mesothelioma, malignant?

While mesothelioma can develop almost anywhere in the body, almost half (53%) is related to asbestos exposure. Asbestos exposure is a risk factor for all the types of mesothelioma. People working with asbestos products, using the material, or building with asbestos-containing materials are at increased risk of developing mesothelioma.

Anonymous Patient Answer

What is the average age someone gets mesothelioma, malignant?

Given that mesothelioma is an uncommon cancer, with the current incidence rate in the USA/Australia, the average age of mesothelioma patients diagnosed is about 50 years. This article provides the average age of the most common mesothelioma cases. It is recommended that mesothelioma patients receive education of this cancer type and preventive activities.

Anonymous Patient Answer

What are the chances of developing mesothelioma, malignant?

The study results imply that a history of exposure to asbestos fibers and pleom effusion are risk indicators for malignant mesothelioma. However, a low risk of developing malignant mesothelioma may be related to smoking and a history of pleom effusion, which indicates an indolent course of malignant mesothelioma. In a recent study, findings provides an index of risk factors in the development of malignant mesothelioma and a theoretical basis for management of patients with respect to the type and severity of malignant mesothelioma.

Anonymous Patient Answer

Have there been any new discoveries for treating mesothelioma, malignant?

Although treatments can be helpful for some of the symptoms of mesothelioma, unfortunately there are not any major discoveries that will change the treatment strategy of this disease. Mesothelioma is still considered a lethal malignant disease, and patients are encouraged to take part in and follow up with any clinical study in this disease.

Anonymous Patient Answer

What is the latest research for mesothelioma, malignant?

Recent research of mesothelioma showed that tumor microvasculature and immune system plays an important role in the development. For mesothelioma, microvessel density and tumor immune cell ratio plays a very important role in prognosis and treatment.

Anonymous Patient Answer

What are the latest developments in gavo-cel for therapeutic use?

Currently, the only gavo-cel therapy for cancer patients with solid tumors is as a treatment of the pain caused by bone metastases from solid tumors. However, gavo-cel may also be used as a treatment for other forms of cancer in patients with bone metastases as an induction or maintenance therapy depending on its specific mode of action. Furthermore, gavo-cel is also used as support to control the progression of the cancer.

Anonymous Patient Answer
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