U87 CAR-T in Patients With Advanced Head and Neck Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Subjects 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- U87 autologous CAR T-cell
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov