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New treatment option for Pancreatic Cancer
Official title TROP2 CAREngineered Cord Blood-Derived NK Cells + Belzutifan In Pancreatic Cancer
ClinicalTrials.gov ID: NCT07377526
What this study is testing
What is TGFBR2 KO CAR27/IL-15 NK cells?
TGFBR2 KO CAR27/IL-15 NK cells is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pancreatic 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
- This is a Phase I/II study evaluating the intraperitoneal delivery of TROP2 CAR/IL-15 TGFBR2 KO NK cells in combination with oral belzutifan (120 mg daily) for patients with recurrent, locally advanced, unresectable and metastatic pancreatic cancer. The primary objectives are to assess safety and determine the recommended Phase II dose (RP2D).
- 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
- people must be 18 years or older.
- people must be willing and able to provide informed consent.
- people with a histologically confirmed diagnosis of pancreatic ductal adenocarcinoma or ampullary-type carcinoma
- people who have progressive disease after receiving initial treatment with either FOLFIRINOX, or a gemcitabine-based therapy
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 3 months...
- If a WOCBP has a positive urine pregnancy test within 72 hours prior to the start of treatment that cannot be confirmed as negative, a serum...
- Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy, alopecia...
- Has received prior radiotherapy within 2 weeks of the start of the study intervention. Participants must have recovered from all radiation-related...
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the...
- Is currently receiving another investigational agent or has used an investigational device within 4 weeks prior to the first dose of study...
See the full eligibility criteria
Who can join
- people must be 18 years or older.
- people must be willing and able to provide informed consent.
- people with a histologically confirmed diagnosis of pancreatic ductal adenocarcinoma or ampullary-type carcinoma
- people who have progressive disease after receiving initial treatment with either FOLFIRINOX, or a gemcitabine-based therapy
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- A female participant is eligible to participate if at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR
- A WOCBP who agrees to follow the contraceptive guidelines in Appendix 1 during the treatment period and for at least 3 months after the last dose of study treatment.
- people must have measurable disease present as defined by modified RECIST v1.1
- people must be at least 5 half-lives from the last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy.
- people must be willing to undergo intraperitoneal port placement and scheduled peritoneal fluid and peripheral blood draws.
- Agree to sign the consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- 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...
- people must have adequate organ function as defined in the following table (Table 2). Specimens must be collected within 10 days prior to the start of study treatment. Table 2: Adequate Organ Function Laboratory Values...
- 1.5 x ULNb ≥30 mL/min for participants with creatinine \> 1.5 x ULNb Hepatic Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \> 1.5 x ULN AST (SGOT) and ALT (SGPT) ≤2.5 x...
- 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the last 2 weeks of the screening test. Participants may be on a stable dose of erythropoietin (≥...
- Serum creatinine and creatinine clearance (CrCl) should be interpreted and calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory...
What rules you out
- Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 3 months after the last dose of trial treatment.
- If a WOCBP has a positive urine pregnancy test within 72 hours prior to the start of treatment that cannot be confirmed as negative, a serum pregnancy test will be required (see Appendix 1).
- Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of...
- Has received prior radiotherapy within 2 weeks of the start of the study intervention. 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 first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Is currently receiving another investigational agent or has used an investigational device within 4 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 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose...
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful...
- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at...
- Active autoimmune disease that has required systemic treatment in the past 2 years (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.
- Active infection requiring systemic therapy.
- Known history of uncontrolled Human Immunodeficiency Virus (HIV) infection. Patients with HIV infection and an undetectable viral load may participate.
- Known history of chronic Hepatitis B or Hepatitis C virus infection.
- Known history of active TB (Bacillus Tuberculosis).
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had an allogenic 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...
- Prolongation of QTcF interval to \>480 ms
- Bleeding or thrombotic disorders or people at risk for severe hemorrhage. people with known deep vein thrombosis/pulmonary embolism who are under appropriate anticoagulation treatment are eligible.
- Radiographic evidence of tumor encasement or invasion of a major blood vessel, or intratumoral cavitation.
- Active peritonitis or diverticulitis
- Medical or surgical history that in the treating physician's opinion would make the subjective not a suitable candidate for intraperitoneal therapy. Examples would include surgically documented extensive intraperitoneal...
- History of severe hypersensitivity reaction with biologic therapy (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.