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NCT Number: NCT05971589

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

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 Interleukin-2 therapy.

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Key information

Conditions

Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The expected survival time is not less than 6 months.
  • Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, head and neck squamous cell cancer, soft tissue sarcoma 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 cm^3) 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Objective response rate (ORR)

    Time frame: through study completion, an average of 1 year estimate

    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.

  2. Duration of response (DOR)

    Time frame: through study completion, an average of 1 year estimate

    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.

  3. Disease control rate (DCR)

    Time frame: through study completion, an average of 1 year estimate

    Disease control rate (DCR) was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease as defined by RECIST version 1.1.

  4. Time to response (TTR)

    Time frame: through study completion, an average of 1 year estimate

    Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.

  5. Time to disease progression (TTP)

    Time frame: through study completion, an average of 1 year estimate

    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 tumor.

  6. Progression free survival (PFS)

    Time frame: through study completion, an average of 1 year estimate

    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.

  7. Overall survival (OS)

    Time frame: through study completion, an average of 1 year estimate

    OS was defined as the time from first dose to date of death from any cause.

  8. Peripheral blood TILs cell survival

    Time frame: through study completion, an average of 1 year estimate

    Detection using flow cytometry

Study contacts

Contact information is provided by the study sponsor or research team.

Jilong yang

CONTACT

[email protected]

+86 22-23340123 ext. 1081

Sponsors and collaborators

Lead sponsor

Suzhou BlueHorse Therapeutics Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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