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New treatment option for Nasopharynx Cancer
Official title U87 CAR-T in Patients With Advanced Head and Neck Tumors
ClinicalTrials.gov ID: NCT06614686
What this study is testing
What is U87 autologous CAR T-cell?
U87 autologous CAR T-cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharynx 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 single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- people have provided informed consent, understanding the study\'s risks and benefits, and are willing to complete the study procedures.
- Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
- ECOG performance status of 0-1.
- Anticipated survival of at least 12 weeks.
- Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
You likely can't join if
- Inadequate washout period from prior anti-cancer treatments before leukapheresis.
- Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
- Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
- Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
- Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
- Active infection requiring intravenous anti-infective therapy.
See the full eligibility criteria
- people have provided informed consent, understanding the study\'s risks and benefits, and are willing to complete the study procedures.
- Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
- ECOG performance status of 0-1.
- Anticipated survival of at least 12 weeks.
- Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
- Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.
- At least one measurable tumor lesion according to RECIST 1.1.
- Suitable venous access for mononuclear cell collection.
- Adequate major organ function.
- Negative pregnancy test for women of reproductive age at screening; sexually active people must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.
- Inadequate washout period from prior anti-cancer treatments before leukapheresis.
- Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
- Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
- Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
- Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
- Active infection requiring intravenous anti-infective therapy.
- Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.
- Primary immunodeficiency or active autoimmune disease.
- Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.
- Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.
- History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
- Allergy to protein drugs or multiple medications.
- Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell/organ transplantation. Uncontrollable third-space fluid accumulation.
- Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events. Pregnant or breastfeeding women.
- Uncontrollable psychiatric history.
- Other conditions deemed unsuitable for study participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. 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.