A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors

NCT ID: NCT05366478

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2029-05-30

Brief Summary

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

Detailed Description

This is an investigator initiated , single-arm, open-label ,exploratory study of LM103 Injection in patients with advanced solid tumors. Expanded TILs will be transferred to the patient after chemotherapy with cyclophosphamide and fludarabine. LM103 will be administered as a single dose on day 1. TIL transfer will be combined with IL-2 treatment. This study is planned to enroll 9-15 patients with advanced solid tumors.

Conditions

Melanoma; Non Small Cell Lung Cancer; Cervical Carcinoma

Study Design

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

Study Groups

Autologous tumor infiltrating lymphocytes (TILs)

In vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors

Group Type: EXPERIMENTAL

Autologous tumor infiltrating lymphocytes (TILs)

Intervention Type: DRUG

A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2.

Interventions

Autologous tumor infiltrating lymphocytes (TILs)

A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2.

Intervention Type: DRUG

Other Intervention Names

LM103

Eligibility Criteria

Inclusion Criteria

1. AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;

2. The patient has residual lesions that can be used for surgical resection (>1.5cm3) or biopsy (>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;

3. Laboratory inspection index requirements:

• Blood routine: lymphocyte ratio > 20%; neutrophil count > 1.0 × 10^9/L; white blood cells > 3.0 × 10^9/L; platelets > 100 × 10^9/L; hemoglobin > 80 g/ L;
• Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5;
• Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5;

4. Left ventricular ejection fraction (LVEF) ≥ 50%;

5. ECOG physical condition is 0 or 1;

6. The expected survival time is more than 3 months;

Exclusion Criteria

1. Suffering from active or previous autoimmune diseases ;

2. Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;

3. Combined with severe infection or persistent infection and cannot be effectively controlled;

4. Central nervous system metastasis and/or cancerous meningitis;

5. With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;

6. Requires systemic steroid therapy;

7. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;

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

Sponsors

Suzhou BlueHorse Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fenge Le, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tianjin Beichen Hospital

Locations

Tianjin Beichen Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xu Wen

Role: CONTACT

zhuce@lanmabio.com

13260921233

Facility Contacts

Li Feng'e

Role: primary

rosetea85@163.com

13821072072

References

Li F, Wang Y, Yan J, Wu H, Du X, Feng W, Zhang X, Xue Y, Wang H, Liu W. Autologous Tumor-Infiltrating Lymphocyte Mono-Therapy Can Rapidly Shrank Tumor in Asian Patient with Stage III/IV Cervical Cancer: Two Cases Report. Int J Womens Health. 2024 Jan 9;16:31-39. doi: 10.2147/IJWH.S446768. eCollection 2024.

Reference Type: DERIVED

PMID: 38222312 (View on PubMed)

Other Identifiers

TIL-2021001

Identifier Type: -

Identifier Source: org_study_id