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

NCT05366478 | Recruiting Phase 1

• 1 other identifier: TIL-2021001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Non Small Cell Lung Cancer; Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  Up to 1 years

Secondary Outcomes (4)

• Number of Participants With Objective Response

  Up to 2 years

• Disease Control Rate (DCR）

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• The changes of the immunoreactivity during treatment

  Up to 2 years

Study Arms (1)

Autologous tumor infiltrating lymphocytes (TILs)

EXPERIMENTAL

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

Drug: Autologous tumor infiltrating lymphocytes (TILs)

Interventions

Autologous tumor infiltrating lymphocytes (TILs) 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.

Also known as: LM103

Autologous tumor infiltrating lymphocytes (TILs)

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;
• 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;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• ECOG physical condition is 0 or 1;
• The expected survival time is more than 3 months;

You may not qualify if:

• Suffering from active or previous autoimmune diseases ;
• Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
• Combined with severe infection or persistent infection and cannot be effectively controlled;
• Central nervous system metastasis and/or cancerous meningitis;
• With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• Requires systemic steroid therapy;
• 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;

Sponsors & Collaborators

• Suzhou BlueHorse Therapeutics Co., Ltd.: lead

Study Sites (1)

Tianjin Beichen Hospital

Tianjin, 300000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38222312 DERIVED

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Fenge Le, Ph.D

  Tianjin Beichen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Wen

CONTACT

13260921233; zhuce@lanmabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 9, 2022
• Study Start: May 30, 2022
• Primary Completion: May 30, 2024
• Study Completion (Estimated): May 30, 2029
• Last Updated: August 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)