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CAR T-cell Therapy
TROP2-CAR-NK Cells for Platinum-Resistant Ovarian Cancer
Phase 1 & 2
Recruiting
Led By Amir Jazaeri, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A histology confirming diagnosis of mesonephric-like adenocarcinoma (MLA) originating from the female reproductive tract or peritoneal lining (including MLA arising from endometriosis) with pathology reviewed at MD Anderson Cancer Center
Subjects must have failed at least one prior line of platinum-containing chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced ovarian cancer that's resistant to other treatments.
Who is the study for?
This trial is for adults with certain types of cancer (high-grade serous ovarian, mesonephric-like adenocarcinoma, or pancreatic) that are resistant to standard treatments. Participants must have an ECOG performance status of 0 or 1, agree to contraception if applicable, and have adequate organ function. They should not be pregnant/breastfeeding and must have failed previous chemotherapy lines.Check my eligibility
What is being tested?
The study tests TROP2-CAR-NK cells delivered into the abdomen combined with Cyclophosphamide and Fludarabine in patients with specific cancers. It aims to find the optimal dose for those whose cancer hasn't responded well to other treatments.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, immune system complications due to CAR-NK cells, as well as typical chemotherapy-related issues like nausea, fatigue, low blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer, originating from the female reproductive tract or peritoneal lining, has been confirmed as mesonephric-like adenocarcinoma by MD Anderson Cancer Center.
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I have had platinum-based chemotherapy before and it did not work.
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My cancer can be measured and is present in my abdomen or lymph nodes near my spine.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer did not respond to at least two chemotherapy treatments or is resistant to platinum-based treatment.
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My cancer progressed after initial treatment with FOLFIRINOX or gemcitabine.
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My tumor shows some level of TROP2 protein.
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I am 18 years old or older.
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I am willing to have a port placed in my abdomen for treatment and to have fluid and blood samples taken regularly.
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My cancer is high grade serous ovarian, peritoneal, or fallopian tube, confirmed by MD Anderson.
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I have a BRCA mutation and have been treated with PARP inhibitors before.
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I have been diagnosed with pancreatic or ampullary-type cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: TROP2-CAR-NKExperimental Treatment3 Interventions
Participants will receive 1 dose of TROP2-CAR-NK and will visit the study clinic up to 16 times to have tests and procedures (such as blood draws, biopsies, and CT scans).
Participants will receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) for 3 days in a row. Participants will receive cyclophosphamide and fludarabine by vein over about 3 hours total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,423 Total Patients Enrolled
93 Trials studying Adenocarcinoma
12,278 Patients Enrolled for Adenocarcinoma
Amir Jazaeri, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is affecting a major blood vessel or has cavities inside it.My cancer can be measured and is present in my abdomen or lymph nodes near my spine.I have not had any cancer treatment or experimental drugs in the last 4 weeks.My cancer, originating from the female reproductive tract or peritoneal lining, has been confirmed as mesonephric-like adenocarcinoma by MD Anderson Cancer Center.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I don't have severe bleeding disorders but can join if I'm being treated for blood clots.You are currently taking or have recently used another experimental treatment or device. If you have finished a previous experimental treatment, you must wait 4 weeks before joining this study.I had radiotherapy over 2 weeks ago, with no ongoing side effects.I have had platinum-based chemotherapy before and it did not work.I am currently on medication for an infection.I have a history of chronic Hepatitis B or C.I currently have an infection in my abdomen.Your heart's electrical activity takes too long to restart after each beat.I have not received a live vaccine in the last 30 days.I am fully active or restricted in physically strenuous activity but can do light work.My cancer did not respond to at least two chemotherapy treatments or is resistant to platinum-based treatment.I have had lung conditions that needed steroids or currently have lung inflammation.You have HIV, it is not under control, and your viral load is detectable.You have had a serious allergic reaction to a type of treatment called biologic therapy, like monoclonal antibodies.My cancer progressed after initial treatment with FOLFIRINOX or gemcitabine.My brain metastases are stable, and I haven't needed steroids for 14 days.I have an active tuberculosis infection.I am not able to have children or will follow birth control guidelines.My tumor shows some level of TROP2 protein.I had another cancer but was treated successfully with no signs of cancer for 2 years, or I had certain skin, bladder, cervical, or in-situ cancers treated successfully.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have recovered from side effects of previous treatments to my normal or mild condition.I have received an organ or tissue transplant from another person.I haven't had major heart problems or strokes in the last year.It has been at least 3 weeks since my last strong cancer drug treatment.I am 18 years old or older.I am willing to have a port placed in my abdomen for treatment and to have fluid and blood samples taken regularly.My organs are functioning well, as confirmed by recent tests.My doctor thinks my medical history makes me unsuitable for intraperitoneal therapy.My cancer is high grade serous ovarian, peritoneal, or fallopian tube, confirmed by MD Anderson.I have a BRCA mutation and have been treated with PARP inhibitors before.I have been diagnosed with pancreatic or ampullary-type cancer.
Research Study Groups:
This trial has the following groups:- Group 1: TROP2-CAR-NK
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any open opportunities for enrollment in this research trial?
"According to clinicaltrials.gov, this particular drug trial is not currently accepting participants. It was first posted on December 31st 2023 and the last edit took place on June 27th 2023; however, there are 1956 other studies that remain open for enrolment at present."
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