An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours

NCT ID: NCT06695689

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2027-10-31

Brief Summary

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

Conditions

Solid Tumor

Study Design

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

Study Groups

LM303

Treatment with LM303 injection

Group Type: EXPERIMENTAL

LM303

Intervention Type: DRUG

Treatment with LM303 injection

Interventions

LM303

Treatment with LM303 injection

Intervention Type: DRUG

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

Locations

Tianjin Beichen Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng e Li

Role: CONTACT

rosetea85@163.com

13821072072

Facility Contacts

Li Feng'e

Role: primary

rosetea85@163.com

13821072072

Other Identifiers

LM303-CO-301

Identifier Type: -

Identifier Source: org_study_id