A Clinical Study on LM103 for the Treatment of Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941936
• Other study ID #: LM103-001
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 19, 2023
• Est. completion date: February 2026

Study information

• Verified date: June 2023
• Source: Suzhou BlueHorse Therapeutics Co., Ltd.
• Contact: Feng'e LI
• Phone: +86 13821072072
• Email: rosetea85[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• LM103
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.

Locations

Country	Name	City	State
China	Tianjin Beichen Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou BlueHorse Therapeutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)	Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.	through study completion, an average of 1 year estimate
Secondary	Objective response rate (ORR)	The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1.	through study completion, an average of 1 year estimate
Secondary	Duration of response (DOR)	Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.	through study completion, an average of 1 year estimate
Secondary	Disease control rate (DCR)	Disease control rate (DCR) was defined as the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST version 1.1.	through study completion, an average of 1 year estimate
Secondary	Time to response (TTR)	Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.	through study completion, an average of 1 year estimate
Secondary	Time to disease progression (TTP)	Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to the solid tomor.	through study completion, an average of 1 year estimate
Secondary	Progression free survival (PFS)	Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST version 1.1) or death due to any cause.	through study completion, an average of 1 year estimate
Secondary	Overall survival (OS)	OS was defined as the time from first dose to date of death from any cause.	through study completion, an average of 1 year estimate
Secondary	Peripheral blood TILs cell survival	Detection using flow cytometry	through study completion, an average of 1 year estimate
Secondary	Lymphocyte subpopulations	CD3+, CD4+, CD8+, CD4+/CD8+.Detection using flow cytometry	through study completion, an average of 1 year estimate
Secondary	Cytokines	IFN- ?? TGF- ß. Detection using flow cytometry	through study completion, an average of 1 year estimate
Secondary	Diversity of Immune repertoire	Sequence and abundance of T Cell Receptor,B Cell Receptor	through study completion, an average of 1 year estimate
Secondary	Changes in T cell transcriptome	Track the changes in the clonal frequency of infused TILs, study the transcriptomic dynamics of memory-, activation-, effector function-, exhaustion-, and metabolic fitness-assocated genes in the infused TILs, GSEA and pathway analysis.	through study completion, an average of 1 year estimate
Secondary	Level of tumor markers	The expression levels of CA50, CA199 and CEA in Melanoma, CA125, SCC and CA199 in cervical cancer/ovarian cancer, CYFRA21-1, SCC and CEA in non-small cell lung cancer, and CEA, TG and SCC in Head and neck cancer	through study completion, an average of 1 year estimate