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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
U87 autologous CAR T-cell
DrugTreatment with U87 chimeric antigen receptor T-cell infusion.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: U87 autologous CAR T-cell injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame
28 days post administration of CAR-T-cellsSecondary outcomes
1
Pharmacokinetics of U87 CAR-T cells
Time at the maximal concentration(Tmax)
Time frame
2 years post CAR T cell infusion2
Pharmacokinetics of U87 CAR-T cells
Area under the concentration-time curve(AUC)
Time frame
2 years post CAR T cell infusion3
Pharmacokinetics of U87 CAR-T cells
The maximal concentration of eripheral blood (Cmax)
Time frame
2 years post CAR T cell infusion4
Pharmacodynamics of U87 CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Time frame
2 years post CAR T cell infusionSponsors and contacts
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Source ClinicalTrials.gov