This was a single arm, open-label, single center, cohort study to determine the efficacy and safety of AMT-116 CAR-T cells in patients with moderate or far advanced non-small cell lung carcinoma (NSCLC) and squamous cell cancer of the head and neck (HNSCC),AMT-253 CAR-T cells in patients with moderate or far advanced melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
1. Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced non-small cell lung carcinoma (NSCLC) enrolled. 2. Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced head and neck Squamous Cell Carcinoma (HNSCC) enrolled.
1.The classic "3 + 3" dose escalation will be applied to 9 selected subjects with moderate or far advanced melanoma by intravenous drip. 2.3 \~ 6 patients with intermediate and advanced melanoma will be injected intratumorally at a dose of ≤ 1 × 10\^8 cells. 3.3 \~ 6 patients with operable advanced melanoma will be treated with postoperative adjuvant treatment at a dose of ≤ 1 × 10\^8 cells ≤ intravenous drip on Day 1 of each 42 days cycle (8 cycle maximum).
The First Affiliated Hospital of Zhengzhou University
Beijing, Beijing Municipality, China
Incidence of adverse events
Time frame: 24 weeks
Overall Response Rate (ORR)
Time frame: 24 weeks
One year recurrence rate
Time frame: 24 weeks
Progression-Free Survival(PFS)
Time frame: 24 weeks
Relapse Free Survival(RFS)
Time frame: 24 weeks
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