NCT05941936RecruitingEarly Phase 1
An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors
Suzhou BlueHorse Therapeutics Co., Ltd.1 site in 1 country5 target enrollmentStarted: May 19, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)
Study Overview
Brief 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 IL-2 therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The expected survival time is not less than 3 months.
- •Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-
- •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 TILs collection.
- •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 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.
- •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.
Outcomes
Primary Outcomes
Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)
Time Frame: through study completion, an average of 1 year estimate
Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.
Secondary Outcomes
- Time to response (TTR)(through study completion, an average of 1 year estimate)
- Progression free survival (PFS)(through study completion, an average of 1 year estimate)
- Overall survival (OS)(through study completion, an average of 1 year estimate)
- Disease control rate (DCR)(through study completion, an average of 1 year estimate)
- Peripheral blood TILs cell survival(through study completion, an average of 1 year estimate)
- Diversity of Immune repertoire(through study completion, an average of 1 year estimate)
- Level of tumor markers(through study completion, an average of 1 year estimate)
- Objective response rate (ORR)(through study completion, an average of 1 year estimate)
- Duration of response (DOR)(through study completion, an average of 1 year estimate)
- Time to disease progression (TTP)(through study completion, an average of 1 year estimate)
- Lymphocyte subpopulations(through study completion, an average of 1 year estimate)
- Cytokines(through study completion, an average of 1 year estimate)
- Changes in T cell transcriptome(through study completion, an average of 1 year estimate)
Investigators
Study Sites (1)
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