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RecruitingNCT05366478Updated Aug 2, 2022

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

A Phase 1 interventional study of Autologous tumor infiltrating lymphocytes (TILs) in Melanoma, Non Small Cell Lung Cancer and Cervical Carcinoma, sponsored by Suzhou BlueHorse Therapeutics Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by Suzhou BlueHorse Therapeutics Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Melanoma
  • Non Small Cell Lung Cancer
  • Cervical Carcinoma
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 15 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Suzhou BlueHorse Therapeutics Co., Ltd. is the lead sponsor of 8 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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)

Interventions

  • DrugAutologous 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.

    Also known as: LM103

06

What researchers measure

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

    Time frame: Up to 1 years

Secondary outcomes

  1. 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.

    Time frame: Up to 2 years

  2. Disease Control Rate (DCR）

    Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1：

    Time frame: Up to 2 years

  3. Progression-Free Survival (PFS)

    The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

    Time frame: Up to 2 years

  4. 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

    Time frame: Up to 2 years

07

Study locations

1 of 1 sites recruiting
  • Tianjin Beichen Hospital
    Tianjin, 300000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05366478
Lead sponsor
Suzhou BlueHorse Therapeutics Co., Ltd.
Responsible party
Sponsor
First posted
May 9, 2022
Start date
May 30, 2022
Primary completion
May 30, 2024 (estimated)
Completion
May 30, 2029 (estimated)
Last update
Aug 2, 2022

Study contacts

Xu Wen
Contact
zhuce@lanmabio.com
13260921233
Fenge Le, Ph.D
principal investigator · Tianjin Beichen Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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