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

NCT05941936 | Recruiting Early Phase 1

• 1 other identifier: LM103-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

• Disease control rate (DCR)

  through study completion, an average of 1 year estimate

• Time to response (TTR)

  through study completion, an average of 1 year estimate

• Time to disease progression (TTP)

  through study completion, an average of 1 year estimate

Study Arms (1)

Intravenous of LM103

EXPERIMENTAL

≥5×10\^9 cells (LM103) will be infused i.v. to patients after NMA lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.

Biological: LM103

Interventions

LM103 BIOLOGICAL

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.

Intravenous of LM103

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou BlueHorse Therapeutics Co., Ltd.: lead

Study Sites (1)

Tianjin Beichen Hospital

Tianjin, 300000, China

RECRUITING

Central Study Contacts

Feng'e LI

CONTACT

+86 13821072072; rosetea85@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 12, 2023
• Study Start: May 19, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 12, 2023

Record last verified: 2023-06

Locations

CN (1)