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

NCT05117138 | Unknown Phase 1

• 1 other identifier: MHSW016
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  24 weeks

• Overall Response Rate (ORR)

  24 weeks

• One year recurrence rate

  24 weeks

Secondary Outcomes (2)

• Progression-Free Survival(PFS)

  24 weeks

• Relapse Free Survival(RFS)

  24 weeks

Study Arms (2)

NSCLC/HNSCC：AMT-116 CAR-T cells

EXPERIMENTAL

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

Biological: AMT-116 CAR-T cells

MEL：AMT-253 CAR-T cells

EXPERIMENTAL

Patients with moderate or far advanced melanoma.

Biological: AMT-253 CAR-T cells

Interventions

AMT-116 CAR-T cells 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.

NSCLC/HNSCC：AMT-116 CAR-T cells

AMT-253 CAR-T cells 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).

MEL：AMT-253 CAR-T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Beijing, Beijing Municipality, 450052, China

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: November 11, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: November 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)