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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

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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.

yizhang@zzu.edu.cn

First Name & Middle Initial & Last Name & Degree

Yi Zhang, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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