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CAR T-cell Therapy

CAR T Cell Therapy for Ovarian and Peritoneal Cancer

Phase 1

Recruiting

Led By Payal D Shah, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

No concurrent treatment for the CNS disease.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is testing a new type of cancer treatment involving genetically modified immune cells.

Who is the study for?

This trial is for adults with advanced stage high grade serous ovarian, fallopian tube, or primary peritoneal cancer that has returned after treatment. Participants must have measurable disease and express a specific protein on their tumors. They should be in good physical condition with proper organ function and not have active infections or other cancers.Check my eligibility

What is being tested?

The study tests MOv19-BBz CAR T cells given through the abdomen to see if they're safe and work against ovarian-type cancers expressing a certain protein. Some patients may also receive chemotherapy drugs cyclophosphamide + fludarabine before the CAR T cells to prepare their bodies.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever, fatigue, changes in blood pressure, difficulty breathing, and organ inflammation. Chemotherapy can cause nausea, hair loss, mouth sores, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am not receiving any treatment for brain or spinal cord disease.

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I am fully active or can carry out light work.

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My cancer is a high-grade serous type in the ovary, fallopian tube, or peritoneum and can be treated with platinum-based therapy or not.

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I have tried at least two chemotherapy treatments for my advanced disease without success.

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I do not have cancer spread to the lining of my brain or spinal cord.

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My tumor shows high levels of aFR.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

Number of study subjects with treatment-related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary outcome measures

Overall response rates (ORR)

Overall survival (OS)

Progression-free survival (PFS)

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort-1: without chemo;only if dose de-escalation requiredExperimental Treatment2 Interventions

Cohort -1: (n= 3 to 6 subjects): Single Infusion of 1-3x106 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. Up to 6 subjects will be infused in Cohort -1 with ≤ 1 DLT/6 subjects to establish the MTD.

Group II: Cohort 3: MOv19-BBz CAR T cells after chemoExperimental Treatment2 Interventions

Cohort 3: (n=3 to 6 subjects): Single infusion of 1-3x108 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Group III: Cohort 2: MOv19-BBz CAR T cells after chemoExperimental Treatment2 Interventions

Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Group IV: Cohort 1: MOv19-BBz CAR T cells without chemoExperimental Treatment2 Interventions

Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ovarian Cancer Alliance of Greater CincinnatiUNKNOWN

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,305 Total Patients Enrolled

285 Trials studying Ovarian Cancer

73,720 Patients Enrolled for Ovarian Cancer

Alliance for Cancer Gene TherapyUNKNOWN

2 Previous Clinical Trials

21 Total Patients Enrolled

Media Library

MOv19-BBz CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03585764 — Phase 1

Ovarian Cancer Research Study Groups: Cohort 1: MOv19-BBz CAR T cells without chemo, Cohort 2: MOv19-BBz CAR T cells after chemo, Cohort 3: MOv19-BBz CAR T cells after chemo, Cohort-1: without chemo;only if dose de-escalation required

Ovarian Cancer Clinical Trial 2023: MOv19-BBz CAR T cells Highlights & Side Effects. Trial Name: NCT03585764 — Phase 1

MOv19-BBz CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03585764 — Phase 1

Frequently Asked Questions

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

Are participants currently being enrolled in this research?

"As per the details provided on clinicaltrials.gov, this research is currently enrolling individuals into its study group. The trial was initially posted in October 2018 and has recently been updated as of September 2022."

Answered by AI

Has the FDA granted approval to MOv19-BBz CAR T cells?

"MOv19-BBz CAR T cells have limited clinical data to support their safety and efficacy, so they were assigned a score of 1."

Answered by AI

What is the sample size of participants enrolled in this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial is actively recruiting patients that were first mentioned in October 2018 and recently updated in September 2022. The study requires 18 individuals from 1 centre for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

2018. "MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03585764.

All > Fallopian Tube Cancer