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Clinical Trials in China / NCT06697665
Recruiting Phase EARLY_PHASE1

An Exploratory Clinical Study to Evaluate the Safety, Tolerability, Immune Response and Preliminary Efficacy of LM103 Injection in Combination With PD-1 in Patients With Advanced Solid Tumours

NCT06697665 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou BlueHorse Therapeutics Co., Ltd.
Phase
Phase EARLY_PHASE1
Started
2024-01-23
Last updated
2024-11-20

Condition(s) studied

Solid Cancer

Investigational drug(s) / intervention(s)

LM103

LM103: Patients were treated with PD-1, cyclophosphamide and fludarabine, LM103 and IL-2 treatment.

Study summary

This is an exploratory clinical study evaluating the safety, tolerability, immune response and preliminary efficacy of LM103 Injection in combination with PD-1 in patients with advanced solid tumours. The research treatment includes LM103 injection, IL-2 therapy, PD-1 therapy,fludarabine and cyclophosphamide.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. The expected survival time is not less than 3 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, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer 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 cm3) or biopsy puncture (no less than 6 lesions) for LM103 manufacturing. 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 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Beichen Hospital China Tianjin Municipality Recruiting

More Suzhou BlueHorse Therapeutics Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06697665 on ClinicalTrials.gov ↗ ← All trials in China