Phase II Study of TAEST16001 in Soft Tissue Sarcoma

NCT05549921 | Unknown Phase 2

• 1 other identifier: TAEST16001 Phase II
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this trial is to evaluate the efficacy and safety of TAEST16001 cells in the treatment of advanced soft tissue sarcoma patients with HLA-A\*02:01 tissue genotype and positive tumor antigen NY-ESO-1 expression.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The objective response rate (ORR), as assessed by an independent imaging evaluation committee (IRC), was used as the endpoint (response evaluation criteria based on solid tumors, version 1.1 \[RECIST1.1\]) to evaluate the TAEST16001 cell therapy tissue genotype as HLA-A\*02:01 and tumor antigen NY-ESO-1 Efficacy of positive expression in patients with advanced soft tissue sarcoma.

  270 days

Secondary Outcomes (12)

• Disease control rate (DCR)

  270 days

• Progression-free survival (PFS)

  270 days

• Duration of response (DOR)

  270 days

• Time to tumor response (TTR)

  270 days

• Overall survival (OS)

  270 days

Study Arms (1)

NY-ESO-1 TCR Specific T cell Therapy

EXPERIMENTAL

This research is divided into two stages, Stage 1 and Stage 2, respectively. In Stage 1, 14 patients with advanced soft tissue sarcoma with positive expression of tumor antigen NY-ESO-1 and HLA-A\*02:01 genotype were enrolled. A further 42 patients will be enrolled in Stage 2, where the primary efficacy analysis will be performed at 3 months after the completion of cell reinfusion in the last subject, with a target ORR of 25%.

Biological: NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)

Interventions

NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy) BIOLOGICAL

NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)

NY-ESO-1 TCR Specific T cell Therapy

Eligibility Criteria

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

You may qualify if:

• Before any research-related operations, they should sign the informed consent Consent Form (ICF) (Genotype and Tumor Antigen Screening and Primary Screening);
• Age ≥18 years, and ≤70 years;
• His/cytology confirmed, unresectable or metastatic soft tissue sarcoma;
• The current stage is the failure of standard treatment (disease progression or recurrence or intolerance, such as chemotherapy, radiotherapy, targeted therapy, etc.) or lack of effective treatment methods, specifically: In addition to acinar soft tissue sarcoma and for pathological subtypes other than epithelioid sarcoma, at least adriamycin or doxorubicin combined with ifosfamide standard chemotherapy regimen should fail or not tolerate chemotherapy; For acinar soft tissue sarcoma and epithelioid sarcoma, need failure or intolerance of previous targeted drugs \[anti-angiogenesis such as Anlotinib, pazopanib, etc.\]; Note: Treatment failure refers to disease progression or inability during treatment or within 3 months of the last treatment Tolerable; disease progression in patients with neoadjuvant or adjuvant therapy \> 6 months after the end of treatment can be considered first-line therapy;
• At least 1 measurable lesion (according to RECIST1.1 criteria \[see Appendix 4 for details\]);
• Genotype and tumor antigen screening must meet the following 2 criteria: HLA-A\*02:01 positive; NY-ESO-1\* positive: immunohistochemical staining positive cells are ≥20%;
• ECOG score of 0-1 and expected survival period of more than 3 months;
• Echocardiography showed left ventricular ejection fraction ≥ 50%;
• Laboratory test results should at least meet the following specified indicators: White blood cell count ≥ 3.0×109 /L; Absolute neutrophil count (ANC) ≥ 1.5×109/L (without G-CSF and GM-CSF support, at least 14 days before lymphadenectomy); Absolute lymphocyte count (ALC) ≥ 0.7× 109/L; Platelet (PLT) ≥ 75×109/L (no blood transfusion therapy 14 days before lymphadenectomy chemotherapy); hemoglobin ≥ 9 g/dL (no blood transfusion therapy 14 days before lymphoid clearing chemotherapy); Coagulation International Normalized Ratio (INR) ≤ 1.5×ULN unless anticoagulant therapy;Partial prothrombin time (APTT) ≤ 1.5×ULN unless anticoagulant therapy; Serum creatinine ≤ 1.5 mg /dL (or 132.6 μmol/L); Creatinine clearance ≥60 mL/min; Aspartate aminotransferase (AST/SGOT)≤2.5×ULN; Alanine aminotransferase (ALT/SGPT)≤2.5×ULN; Total bile red Prime (TBIL)≤1.5×U LN; Note: If patients with liver metastases or patients with primary liver tumor lesions, aspartate aminotransferase and alanine aminotransferase should be ≤5× ULN;
• Females of childbearing age who have not received sterilization before menopause must agree to be removed from the study treatment (clearing). effective contraceptive measures should be used from the beginning of the last cell infusion to one year after the last cell infusion, and the serum pregnancy test was negative within 14 days before the first cell infusion; ) and up to one year after the last cell infusion, use effective contraception.

You may not qualify if:

• Received the last leukocyte apheresis within 4 weeks. Anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, tumor embolization or traditional Chinese medicine with anti-tumor indications, etc.); immunotherapy within 1 month before the signing of the main informed consent;
• days before cell infusion received live attenuated vaccine within 1 week;
• Patients with ≥3 bone metastases;
• Known to have allergic reactions to any components used in the treatment of this study;
• No previous surgery or treatment-related adverse reactions recovered to \<Grade 2 CTCAE v5.0;
• Patients with a history of meningeal metastasis or central nervous system metastasis, or patients with clear underlying diseases of the central nervous system within 6 months before cell reinfusion, and left significant symptoms;
• Uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg) or clinically significant (eg active) cardiovascular and cerebrovascular diseases, such as cerebrovascular accident within 1 month), myocardial infarction (within 6 months before signing the main informed consent), unstable angina, congestive heart failure with New York Heart Association (NYHA) class II or above, or severe arrhythmia that cannot be treated with drugs Control or have potential impact on study treatment; ECG results show clinically significant abnormality or average QTcF ≥ 450 ms in 3 consecutive times (at least 5 minutes between each time) (see Appendix 2 for the formula);
• Combined with other serious devices;
• Patients with systemic active infections that require treatment, including but not limited to active tuberculosis, known HIV-positive patients or clinically active hepatitis A, B, and C patients, including virus carriers;
• Patients with autoimmune diseases: those with a history of inflammatory bowel disease and a history of autoimmune diseases judged by the investigator to be unsuitable for this study, such as systemic lupus erythematosus, vasculitis, and infiltrative lung disease, should be excluded ( (except for vitiligo and psoriasis that do not require systemic immunosuppressive therapy);
• G-CSF or GM-CSF has been used within 2 weeks before leukapheresis, or within 4 weeks before cell reinfusion and planned to be used during the study period (If there is long-term use) systemic cortisone steroids, hydroxyurea, immunomodulatory drugs (eg: alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.);
• Organ isotypes History of transplantation, allogeneic stem cell transplantation and renal replacement therapy;
• Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;
• Known alcohol and/or drug abuser;
• Pregnant or lactating women;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangdong Xiangxue Precision Medical Technology Co., Ltd.: collaborator

Study Sites (2)

Sun Yat-Sen Univerisity Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Peking University Cancer Hospital & Institute

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Xing Zhang, PhD, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xing Zhang, PhD, MD

CONTACT

862087343192; zhangxing@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of sarcoma and melanoma, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 22, 2022
• Study Start: July 8, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (2)