A Clinical Study on TILs for the Treatment of Advanced Solid Tumors

NCT ID: NCT05971576

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2026-08-31

Brief Summary

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous of LM103

≥5×10\^9 cells (LM103) will be infused i.v. to patients after non-myeloablative lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.

Group Type: EXPERIMENTAL

LM103

Intervention Type: BIOLOGICAL

Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.

Interventions

LM103

Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. The expected survival time is not less than 3 months.

2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.

3. Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.

4. The patient has lesions that can be used for surgical resection (>1.5 cm3) or biopsy puncture (no less than 6 lesions) for TILs collection.

5. At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).

6. Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria

1. Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).

2. LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.

3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).

4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou BlueHorse Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhiyu Wang

Role: CONTACT

327369979@qq.com

+86 13831195070

Other Identifiers

LM103-002

Identifier Type: -

Identifier Source: org_study_id