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

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Non Small Cell Lung Cancer; Cervical Carcinoma
• Intervention / Treatment: Drug: Autologous tumor infiltrating lymphocytes (TILs)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xu Wen; Phone Number: 13260921233; Email: zhuce@lanmabio.com

Study Locations

• China
  • Tianjin, China, 300000
    • Recruiting
    • Tianjin Beichen Hospital
    • Contact: Li Feng'e; Phone Number: 13821072072; Email: rosetea85@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous tumor infiltrating lymphocytes (TILs); In vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors	Drug: 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.; Other Names: LM103

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Objective Response	Participants displaying objective response associated with the treatment regimen per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.	Up to 2 years
Disease Control Rate (DCR）	Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1：	Up to 2 years
Progression-Free Survival (PFS)	The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1	Up to 2 years
The changes of the immunoreactivity during treatment	The changes from baseline of systemic immune Response markers: peripheral blood lymphocyte subtypes counts, cytokine, antigen-specific T-lymphocytes	Up to 2 years

Collaborators and Investigators

• Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.
• Investigators: Principal Investigator: Fenge Le, Ph.D, Tianjin Beichen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): May 30, 2029

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TIL-2021001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No