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Alkylating agents

Genetically Modified T Cells for Ovarian Cancer

Phase 1

Waitlist Available

Led By Roisin O'Cearbhaill, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of measurable recurrence, with RECIST measurable disease at the time of intervention consent

Patients must have had one prior platinum-based chemotherapeutic regimen for management of ovarian, primary peritoneal, or fallopian tube carcinoma and at least two prior chemotherapy regimens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the safety of using specially prepared cells to treat ovarian cancer. The goal is to find a safe dose and to see what effects the cells have on the patient and their cancer.

Who is the study for?

This trial is for adults with high-grade serous ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred. They must have measurable disease, a life expectancy of over 3 months, and no recent cancer treatments. Their tumors should express MUC16ecto antigen and they've had at least one platinum-based chemotherapy. Exclusions include bowel obstruction, autoimmune diseases (except stable thyroid), brain metastases, seizure history, significant heart conditions, active infections like hepatitis B/C or HIV.Check my eligibility

What is being tested?

The study tests the safety of different doses of modified T cells targeting the MUC16 protein on certain solid tumors. It involves collecting patients' T cells and genetically modifying them to attack tumor cells before being infused back into the patient's body along with pre-treatment drugs Cyclophosphamide and Fludarabine.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation in various organs due to targeted cell destruction by modified T cells; complications from infusion procedures; effects from pre-treatment drugs like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has returned and can be measured for its size.

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I have had one platinum-based and at least two other chemotherapy treatments for ovarian, peritoneal, or fallopian tube cancer.

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I am able to care for myself but cannot do normal activities or work.

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My cancer tests positive for the MUC16ecto antigen.

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I am 18 years old or older.

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My blood, kidney, and liver tests are within normal ranges.

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I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

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I haven't had cancer treatment in the last 3 weeks and no immunotherapy in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

maximum tolerated dose (MTD)

Secondary outcome measures

evidence of anti-tumor activity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cyclophosphamide followed by Autologous T CellsExperimental Treatment5 Interventions

Cohorts of 3-6 pts will be infused with escalating doses of modified T cells to establish the MTD of modified T cells. There are 5 planned dose levels: 3 x 10^5, 1 x 10^6, 3 x 10^6, & 1 x 10^7 & 3 x 10^7 4H11-28z/fIL-12/EGFRt+ T cells/kg. Cohort I-IV & VI will be treated escalating dose levels. Once the MTD of T cells is established, the next cohort will receive lymphodepleting cyclophosphamide dose of 750 mg/m^2 or a regimen of cyclophosphamide dose 300 mg/m2 x 3 days concurrent with fludarabine dose 25-30 mg/m2 x 3 days 2-7 days prior to starting the T cell infusion at one dose level below the MTD. If MTD isn't established after Cohort IV, Cohort V will receive conditioning chemotherapy 2-7 days prior to starting the T cell infusion at the same dose as Cohort III. Pts in Cohort V received cyclophosphamide chemotherapy on Day 1 or cyclophosphamide concurrent with fludarabine on Day 1-3, followed 2 to 4 days later by T cell infusion. This cohort is closed to further accrual.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Fludarabine

2012

Completed Phase 3

~1100

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,602 Total Patients Enrolled

Stanford UniversityOTHER

2,386 Previous Clinical Trials

17,333,990 Total Patients Enrolled

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry Sponsor

14 Previous Clinical Trials

1,709 Total Patients Enrolled

Frequently Asked Questions

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

What have been the outcomes of past experiments concerning administration of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells?

"Currently, 889 medical trials are in progress for Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells. Of these studies, 161 have progressed to the third phase and 28446 clinical trial sites now offer this intervention. Philadelphia is leading with most locations providing this particular treatment option."

Answered by AI

How many individuals are currently being recruited to participate in this trial?

"This particular trial has closed its recruitment. Initially posted on August 1st 2015 and last updated on September 1st 2022, this study is no longer seeking participants. While the search for cancer treatments continues, 2585 studies related to solid tumors are actively recruiting patients, including 889 trials involving the Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells."

Answered by AI

Are trial participants being accepted at this time?

"Data hosted on clinicaltrials.gov displays that this trial is no longer enrolling new patients, with the last update being made September 1st 2022. However, there are still 3474 medical studies recruiting participants at current."

Answered by AI

To what diseases is the Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells commonly applied?

"Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells can be utilized to manage multiple sclerosis, mixed cell type lymphoma, and acute myelocytic leukemia."

Answered by AI

Has the FDA sanctioned the infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells?

"The safety of Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells was assessed at a score 1 due to the relative lack of clinical data regarding both efficacy and safety during Phase 1 trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

2015. "Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02498912.