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

Last updated: November 17, 2024
Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

All Solid Tumors

Treatment

LM103

Clinical Study ID

NCT06697665
LM-CM-TIL
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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: advancedMelanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer,non-small cell lung cancer, esophageal cancer and other solid tumors that havefailed standard treatment regimens, cannot tolerate standard treatment, refuse or donot have standard treatment regimens available.

  4. The patient has lesions that can be used for surgical resection (>1.5 cm3) or biopsypuncture (no less than 6 lesions) for LM103 manufacturing.

  5. At least one measurable lesion as the target lesion after collecting tumor tissuefrom the patient (RECIST v1.1 criteria).

  6. Laboratory tests results during the screening period indicate that the subjects havesufficient organ function.

Exclusion

Exclusion Criteria:

  1. Have a medical history of other malignant tumors other than the disease under studyin the past 5 years, except for malignant tumors that can be expected to recoverafter treatment (including but not limited to thyroid cancer, cervical Carcinoma insitu, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breasttreated by radical surgery).

  2. LM103 received systematic therapy of antineoplastic drugs (including chemotherapy,small molecule targeted drug therapy, Hormone replacement therapy, etc.), or localantineoplastic therapy (such as radiotherapy, palliative radiotherapy for bonemetastases>2 weeks before the start of the study and intracranial stereotacticradiotherapy or resection of a single brain metastasis>3 weeks before the start ofthe study were acceptable) within 4 weeks before LM103 infusion; Or receivedclinical 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 beendetermined by the researchers to be irreparable and level 2 hypothyroidism for along time).

  4. Previously received allogeneic hematopoietic stem cell transplantation or solidorgan transplantation.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: LM103
Phase: 1
Study Start date:
January 23, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Tianjin Beichen Hospital

    China, Tianjin 300000
    China

    Active - Recruiting

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