NCT05117138UnknownPhase 1
Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
Beijing Immunochina Medical Science & Technology Co., Ltd.1 site in 1 country39 target enrollmentStarted: January 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: 24 weeks
Overall Response Rate (ORR)
Time Frame: 24 weeks
One year recurrence rate
Time Frame: 24 weeks
Secondary Outcomes
- Progression-Free Survival(PFS)(24 weeks)
- Relapse Free Survival(RFS)(24 weeks)
Investigators
Study Sites (1)
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