Recruiting NCT06697665
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LM103.
- Who it may be relevant to
- Registry conditions: Solid Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological LM103
Patients were treated with PD-1, cyclophosphamide and fludarabine, LM103 and IL-2 treatment.
Primary outcome measures
- Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE) [Time frame: through study completion, an average of 1 year estimate]
Secondary outcome measures (7)
- Objective response rate (ORR) [Time frame: through study completion, an average of 1 year estimate]
- Duration of response (DOR) [Time frame: through study completion, an average of 1 year estimate]
- Disease control rate (DCR) [Time frame: through study completion, an average of 1 year estimate]
- Time to response (TTR) [Time frame: through study completion, an average of 1 year estimate]
- Time to disease progression (TTP) [Time frame: through study completion, an average of 1 year estimate]
- Progression free survival (PFS) [Time frame: through study completion, an average of 1 year estimate]
- Overall survival (OS) [Time frame: through study completion, an average of 1 year estimate]
Eligibility criteria
Inclusion criteria
- The expected survival time is not less than 3 months.
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
- 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.
- 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.
- At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
- Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.
Exclusion criteria
- 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).
- 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.
- 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).
- Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Beichen Hospital — China
Publications
- Li F, Xu Y, Wang Y, Mu N, Liu M, Feng W, Xue Y, Wu S, Wang X, Lizee G, Ma C. Multiple autologous tumor-infiltrating lymphocyte (LM103 infusion) therapy combined with immune checkpoint inhibitor induces repeated tumor regression in a patient with aggressive mucosal melanoma: a case report and literature review. Front Oncol. 2026 Apr 23;16:1789442. doi: 10.3389/fonc.2026.1789442. eCollection 2026. PMID 42109657
Identifiers
NCT: NCT06697665 · LM-CM-TIL