Actively Recruiting
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
Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2024-11-20
10
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected survival time of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Confirmed advanced solid tumors including melanoma, cervical cancer, ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer, or other solid tumors that have failed or cannot tolerate standard treatments
- Presence of lesions suitable for surgical removal (>1.5 cm3) or biopsy (at least 6 lesions) for LM103 manufacturing
- At least one measurable target lesion after tumor tissue collection according to RECIST v1.1 criteria
- Laboratory tests indicating adequate organ function during screening
You will not qualify if you...
- History of other malignant tumors in the past 5 years except certain treated cancers expected to be cured
- Received systemic or local antineoplastic therapy within 4 weeks before LM103 infusion, except specified acceptable radiotherapy
- Unresolved adverse reactions from previous treatments worse than CTCAE grade 1 (excluding certain exceptions)
- Prior allogeneic hematopoietic stem cell or solid organ transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Beichen Hospital
China, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
F
fenge L doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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