U87 CAR-T treatment for advanced head and neck tumors
A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors
This study is testing a new CAR-T cell therapy to see if it can help people with advanced head and neck tumors when other treatments haven't worked.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06614686 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of an autologous CAR T-cell therapy using U87 injection solution in patients with advanced malignant head and neck tumors. Eligible participants will undergo a leukapheresis procedure to collect their own mononuclear cells, which will be used to manufacture the investigational drug product. Following the manufacturing process, patients will receive preconditioning before the U87 infusion and will be monitored for long-term safety. The study aims to provide insights into a novel treatment approach for patients with limited options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with advanced malignant head and neck cancer and positive Trop2 expression.
Not a fit: Patients with early-stage head and neck cancer or those with effective standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced head and neck cancers that currently have no effective standard treatments.
How similar studies have performed: While CAR T-cell therapies have shown promise in other cancers, this specific approach using U87 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Subjects have provided informed consent, understanding the study\'s risks and benefits, and are willing to complete the study procedures.
2. Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
3. ECOG performance status of 0-1.
4. Anticipated survival of at least 12 weeks.
5. Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
6. Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.
7. At least one measurable tumor lesion according to RECIST 1.1.
8. Suitable venous access for mononuclear cell collection.
9. Adequate major organ function.
10. Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.
Exclusion Criteria:
1. Inadequate washout period from prior anti-cancer treatments before leukapheresis.
2. Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
3. Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
4. Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
5. Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
6. Active infection requiring intravenous anti-infective therapy.
7. Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.
8. Primary immunodeficiency or active autoimmune disease.
9. Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.
10. Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.
11. History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
12. Allergy to protein drugs or multiple medications.
13. 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.
14. Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.
Pregnant or breastfeeding women.
15. Uncontrollable psychiatric history.
16. Other conditions deemed unsuitable for study participation by the investigator.
Where this trial is running
Shanghai
- Eye ENT Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Haitao Wu, Ph.D
- Email: eentwuhaitao@163.com
- Phone: 13585504678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.