NCT05117138

Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma
• Non-small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	AMT-116 CAR-T cells	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.
BIOLOGICAL	AMT-253 CAR-T cells	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).

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-01
• Completion: 2024-03-01
• First posted: 2021-11-11
• Last updated: 2021-11-11

Locations

1 site across 1 country: China