Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
Primary Purpose
Melanoma, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AMT-116 CAR-T cells
AMT-253 CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- The First Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NSCLC/HNSCC:AMT-116 CAR-T cells
MEL:AMT-253 CAR-T cells
Arm Description
Patients with moderate or far advanced non-small cell lung carcinomav or head and neck Squamous Cell Carcinoma.
Patients with moderate or far advanced melanoma.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Overall Response Rate (ORR)
One year recurrence rate
Secondary Outcome Measures
Progression-Free Survival(PFS)
Relapse Free Survival(RFS)
Full Information
NCT ID
NCT05117138
First Posted
September 6, 2021
Last Updated
November 9, 2021
Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05117138
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NSCLC/HNSCC:AMT-116 CAR-T cells
Arm Type
Experimental
Arm Description
Patients with moderate or far advanced non-small cell lung carcinomav or head and neck Squamous Cell Carcinoma.
Arm Title
MEL:AMT-253 CAR-T cells
Arm Type
Experimental
Arm Description
Patients with moderate or far advanced melanoma.
Intervention Type
Biological
Intervention Name(s)
AMT-116 CAR-T cells
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
AMT-253 CAR-T cells
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
24 weeks
Title
Overall Response Rate (ORR)
Time Frame
24 weeks
Title
One year recurrence rate
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Progression-Free Survival(PFS)
Time Frame
24 weeks
Title
Relapse Free Survival(RFS)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
450052
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhang, M.D.
Email
yizhang@zzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yi Zhang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
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