A Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T-cell (CART) in the Treatment of Solid Tumors

NCT05745454 | Unknown

• 1 other identifier: HER2-E-CART
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, investigator-initiated exploratory study.The study is designed to evaluate the safety and the tolerability of HER2-E-CART cells for the treatment of patients with HER2-positive, refractory advanced solid tumors in three dose groups: low, medium and high.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Occurence of Adverse event rate

  The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

  Adverse events will be collected from the beginning to the end of the study, up to 2 years after the last cell transfusion

Secondary Outcomes (15)

• Time to peak of serum cytokine Interleukin-2

  Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.

• Time to peak of serum cytokine Interleukin-6

  Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.

• Time to peak of serum cytokine Interleukin-10

  Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.

• Time to peak of serum cytokine Tumor Necrosis Factor-α

  Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.

• Time to peak of serum cytokine Tumor Necrosis Factor-γ

  Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.

Study Arms (1)

HER2-E-CART cells

EXPERIMENTAL

HER2-E-CART cells were intravenously transfused and followed up to 2 years after the last cell transfusion

Biological: HER2-E-CART cells

Interventions

HER2-E-CART cells BIOLOGICAL

E-CAR-T is a novel second-generation CAR-T product targeting HER2 protein

HER2-E-CART cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed an informed consent form and were able to complete the study procedures and follow-up examinations and treatment
• Age ≥ 18 years and ≤ 70 years, regardless of gender
• Weight \> 40 kg
• Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1
• Patients with refractory advanced solid tumors who have failed or are intolerant of existing standard regimens or whose patients have refused standard regimens
• The presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors 1.1 criteria
• With good organ function
• Positive HER2 cell membrane expression
• Women of childbearing potential must have a pregnancy test with negative results within 7 days prior to initiation of treatment

You may not qualify if:

• Any systemic antitumor therapy within 2 weeks prior to the single blood collection
• History of organ transplantation
• Pregnant or lactating women
• Uncontrolled infectious disease, such as baseline Hepatitis B Virus DNA ≥ 1000 IU/ml, anti-HIV positive, Hepatitis C Virus-RNA positive
• Other clinically significant active infections
• Other active malignancies within the previous 5 years, such as basal or squamous skin cancer, superficial bladder cancer, or in situ breast cancer that has been completely cured and does not require follow-up treatment subjects are not included
• Patients with severe autoimmune or immunodeficiency diseases, such as subjects with a confirmed diagnosis of a severe autoimmune disease requiring systemic immunosuppressive (steroid) therapy for a prolonged period of time (more than 2 months) or with immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis), etc
• Subjects with known severe allergic reactions to pretreatment drugs such as injectable cyclophosphamide, injectable paclitaxel (albumin-bound), or CAR-T cell preparations including adjuvants, dimethylsulfoxide
• Any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification ≥ Class III congestive heart failure, severe arrhythmias poorly controlled by medications, liver, kidney or metabolic disease, and hypertension uncontrolled by standard therapy 10
• Those with active bleeding, thrombotic disorders requiring treatment
• Patients with pericardial, thoracic, or abdominal effusions requiring clinical management or intervention
• The presence of known or suspected brain metastases, including central nervous system and spinal cord compressions or meningeal metastases
• Subjects undergoing treatment with systemic steroids or steroid inhalers
• Subjects with any psychiatric disorder, including dementia, altered mental status, that may interfere with informed consent and understanding of relevant questionnaires
• Having participated in another clinical trial within the previous 30 days

Sponsors & Collaborators

• su haichuan: lead

Study Officials

• Haichuan Su, Doctor

  The Second Affiliated Hospital of PLA Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haichuan Su, Doctor

CONTACT

18629190366; cntdgcp@163.com

Song Yang, Doctor

CONTACT

13991108870; songyang212212@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: February 27, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: February 27, 2023

Record last verified: 2023-02