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Trial Title:
A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors
NCT ID:
NCT05971589
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LM103
Description:
Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be
extracted and reinfused to corresponding patients after ex vivo stimulation, activation
and extensive expansion.
Arm group label:
Intravenous of LM103
Summary:
This study is an open exploratory clinical study to evaluate the safety, tolerance,
immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103
injection in advanced solid tumor patients. The research treatment includes fludarabine
and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and
Interleukin-2 therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The expected survival time is not less than 6 months.
2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Patients with advanced solid tumors confirmed by histology or cytology: advanced
Melanoma, head and neck squamous cell cancer, soft tissue sarcoma and other solid
tumors that have failed standard treatment regimens, cannot tolerate standard
treatment, refuse or do not have standard treatment regimens available.
4. The patient has lesions that can be used for surgical resection (>1.5 cm^3) or
biopsy puncture (no less than 6 lesions) for TILs collection.
5. At least one measurable lesion as the target lesion after collecting tumor tissue
from the patient (RECIST v1.1 criteria).
6. Laboratory tests results during the screening period indicate that the subjects have
sufficient organ function.
Exclusion Criteria:
1. Have a medical history of other malignant tumors other than the disease under study
in the past 5 years, except for malignant tumors that can be expected to recover
after treatment (including but not limited to thyroid cancer, cervical Carcinoma in
situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast
treated by radical surgery).
2. LM103 received systematic Sex therapy of antineoplastic drugs (including
chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy,
etc.), or local antineoplastic therapy (such as radiotherapy, palliative
radiotherapy for bone metastases>2 weeks before the start of the study and
intracranial stereotactic radiotherapy or resection of a single brain metastasis>3
weeks before the start of the study were acceptable) within 4 weeks before LM103
infusion; Or received clinical investigational drugs or equipment treatment.
3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version
5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been
determined by the researchers to be irreparable and level 2 hypothyroidism for a
long time).
4. Previously received allogeneic hematopoietic stem cell transplantation or solid
organ transplantation.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 2023
Completion date:
August 2026
Lead sponsor:
Agency:
Suzhou BlueHorse Therapeutics Co., Ltd.
Agency class:
Industry
Source:
Suzhou BlueHorse Therapeutics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05971589
