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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05117138
• Other study ID #: MHSW016
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2021
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• AMT-116 CAR-T cells
Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced non-small cell lung carcinoma (NSCLC) enrolled. Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced head and neck Squamous Cell Carcinoma (HNSCC) enrolled.
• 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).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		24 weeks
Primary	Overall Response Rate (ORR)		24 weeks
Primary	One year recurrence rate		24 weeks
Secondary	Progression-Free Survival(PFS)		24 weeks
Secondary	Relapse Free Survival(RFS)		24 weeks