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New treatment option for Colorectal Cancer
Official title Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial ("Chip-CRC Trial")
ClinicalTrials.gov ID: NCT07411599
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find the highest dose of NK cells that can be given by vein and intraperitoneally (given directly into the abdominal cavity) in combination with cetuximab to patients with colorectal cancer that has spread to the peritoneum.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria
- people must be 18 years or older. Because no dosing or adverse event data are currently available on the use of IP/IV TROP2 CAR/IL-15 TGFBR2 KO NK...
- people must be at least 4 weeks from their last dose of systemic cytotoxic chemotherapy at the time of their diagnostic laparoscopy (DL)/IP catheter...
- people must be willing to undergo DL and IP catheter placement along with scheduled peritoneal fluid/peripheral blood draws and biopsies.
- people must have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study...
You likely can't join if
- Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with screening visit through 4 months after...
- Participants with BRAFV600E mutated tumors (determined by Next Generation Sequencing, NGS) will be excluded.
- Has received systemic anti-cancer therapy within 4 weeks of their scheduled diagnostic laparoscopy (DL)/IP catheter placement or 6 weeks if the...
- Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy, alopecia, or...
- Has received prior radiotherapy within 2 weeks of the start of study intervention (DL). Participants must have recovered from all radiation-related...
- Has received a live vaccine within 30 days prior to the initiation of LD chemotherapy. Examples of live vaccines include, but are not limited to, the...
See the full eligibility criteria
Who can join
- Eligibility Criteria
- people must be 18 years or older. Because no dosing or adverse event data are currently available on the use of IP/IV TROP2 CAR/IL-15 TGFBR2 KO NK Cell Therapy + Cetuximab in participants 3 liver metastases, \>5 lung...
- people must be at least 4 weeks from their last dose of systemic cytotoxic chemotherapy at the time of their diagnostic laparoscopy (DL)/IP catheter placement or 6 weeks if the chemotherapy regimen included Bevacizumab...
- people must be willing to undergo DL and IP catheter placement along with scheduled peritoneal fluid/peripheral blood draws and biopsies.
- people must have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study treatment.
- Participant s must have histologically confirmed microsatellite stable (MSS) CRC-related PM that is not amenable to curative resection (participant determined not to be a candidate for CRS +/- HIPEC by surgical...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Women of childbearing potential (WOCBP): The effects of CAR NK therapy on the developing human fetus are unknown. For this reason and because lymphodepleting (LD) chemotherapy agents as well as other therapeutic agents...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months). o History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of TROP2 CAR/IL-15 TGFBR2 KO NK cells...
What rules you out
- Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with screening visit through 4 months after last dose of trail treatment (TROP2 CAR/IL-15 TGFBR2 KO NK cell...
- Participants with BRAFV600E mutated tumors (determined by Next Generation Sequencing, NGS) will be excluded.
- Has received systemic anti-cancer therapy within 4 weeks of their scheduled diagnostic laparoscopy (DL)/IP catheter placement or 6 weeks if the regimen included Bevacizumab. Or has received systemic chemotherapy of any...
- Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy, alopecia, or other AEs may be deemed eligible at the discretion of the PI. If a...
- Has received prior radiotherapy within 2 weeks of the start of study intervention (DL). Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation...
- Has received a live vaccine within 30 days prior to the initiation of LD chemotherapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox)...
- Is currently receiving another investigational agent or has used an investigational device within 6 weeks prior to the first dose of study intervention. Participants who have entered the follow-up phase of an...
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose...
- High-volume extra-peritoneal visceral metastases to include but are not limited to, high volume (\>3) liver metastases, high volume (\>5) lung metastases, CNS metastases (any number) and/or carcinomatous meningitis...
- Active autoimmune disease that has required systemic treatment in the past 2 months (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin...
- History of interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Serious active infection requiring intravenous systemic therapy.
- Uncontrolled Human Immunodeficiency Virus (HIV) infection. Participants with HIV who have an undetectable viral load and a CD4 count of at least 400 cells/mm3 may participate.
- Known Hepatitis B Virus (HBV) not on suppressive therapy or with detectable viral load on suppressive therapy. If undetectable viral load on suppressive therapy, OK to participate.
- Known Hepatitis C Virus who has not been treated or cured, or who is currently being treatment with a detectable viral load. If cured or being treated with an undetectable viral load, OK to participate.
- Known history of active Tuberculosis (TB).
- History or current evidence of any condition, therapy, or laboratory abnormalities that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had allogeneic tissue/solid organ transplant.
- Clinically significant cardiovascular disease within 12 months from the first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial...
- Prolonged QTcF interval to \>480 ms.
- Bleeding or thrombotic disorders or people at risk of severe hemorrhage. Subject with known deep vein thrombosis/pulmonary embolism that are under appropriate anticoagulation treatment are eligible.
- Radiographic distribution of disease that in the investigator's opinion would impart excessive risk to participation to this protocol.
- Active peritonitis or diverticulitis.
- Medical or surgical history that in the treating physician's opinion would make the subject not a suitable candidate for intraperitoneal therapy. Examples would include surgically documented extensive intraperitoneal...
- History of severe hypersensitivity reaction with biologic therapies (e.g. monoclonal antibodies).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.