Clinical trial NCT05117138: Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
Official title: Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Melanoma
Non-small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 24 weeks
measure: Overall Response Rate (ORR)
timeFrame: 24 weeks
measure: One year recurrence rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Progression-Free Survival(PFS)
timeFrame: 24 weeks
measure: Relapse Free Survival(RFS)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Beijing
Study officials:
References: