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RecruitingNCT06695689Updated Nov 19, 2024

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

An Early Phase 1 interventional study of LM303 in Solid Tumor, 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 2024-11-19.

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

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
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 LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

02

Conditions studied

  • Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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

Study arms

  • Experimental
    LM303

    Treatment with LM303 injection

    Drug: LM303

Interventions

  • DrugLM303

    Treatment with LM303 injection

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: Undecided

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 Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06695689
Lead sponsor
Suzhou BlueHorse Therapeutics Co., Ltd.
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Oct 17, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 19, 2024

Study contacts

Feng e Li
Contact
rosetea85@163.com
13821072072

Oversight

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

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