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

NCT ID: NCT05117138

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NSCLC/HNSCC：AMT-116 CAR-T cells

Patients with moderate or far advanced non-small cell lung carcinomav or head and neck Squamous Cell Carcinoma.

Group Type: EXPERIMENTAL

AMT-116 CAR-T cells

Intervention Type: BIOLOGICAL

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.

MEL：AMT-253 CAR-T cells

Patients with moderate or far advanced melanoma.

Group Type: EXPERIMENTAL

AMT-253 CAR-T cells

Intervention Type: BIOLOGICAL

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age 18-70 years old, both men and women, and the survival period is more than 6 months.
• At least one assessable focus, failure of previous multi-line treatment or stable condition after treatment.
• Patients with melanoma confirmed by histopathology, patients with non-small cell lung cancer(squamous carcinoma) and head and neck squamous cell carcinoma.
• The surgically removed pathological tissue can be used for immunohistochemical detection of target protein (paraffin section should be within 5 years), and the positive expression of target protein in line with pathological diagnosis (immunohistochemical staining + + or + + +).
• Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection.
• Routine blood examination: white blood cell count (WBC) ≥ 3 × 10^9 / L, lymphocyte count (ly) ≥ 0.8 × 10^9 / L, hemoglobin (HB) ≥ 90g / L, platelet (PLT) ≥ 80 × 10^9/L.
• Liver and kidney function: alanine aminotransferase and aspartate aminotransferase < 3 ULN, total bilirubin (TBIL) < 1.5 ULN, serum creatinine (SCR) < 2 ULN.
• The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion Criteria

• Active hepatitis B or hepatitis C virus, HIV infection, or other unhealed active infections.
• Patients with second tumor.
• Patients previously treated with car-t cells.
• Requiring long-term use of immunosuppressants for any reason.
• Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
• Subjects with severe heart, lung, liver and kidney dysfunction or severe lung diseases.
• Current systemic use of steroid cells (except for recent or current use of inhaled steroids).
• Pregnant and lactating subjects.
• Allergic to immunotherapy and related cells.
• Subjects with a history of organ transplantation or waiting for organ transplantation.
• After evaluation, the investigator considered that the subjects were unable or unwilling to comply with the requirements of the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Zhengzhou University

Beijing, Beijing Municipality, China

Countries

China

Facility Contacts

Yi Zhang, M.D.

Role: primary

Other Identifiers

MHSW016

Identifier Type: -

Identifier Source: org_study_id