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

NCT06697665 | Recruiting Early Phase 1

• 1 other identifier: LM-CM-TIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Cancer

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 (7)

• 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)

Participant Group

EXPERIMENTAL

Treatment includes LM103 injection and PD-1

Biological: LM103

Interventions

LM103 BIOLOGICAL

Patients were treated with PD-1, cyclophosphamide and fludarabine, LM103 and IL-2 treatment.

Participant Group

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 LM103 manufacturing.
• 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 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

China, Tianjin Municipality, 300000, China

RECRUITING

Central Study Contacts

fenge L doctor

CONTACT

86+13821070272; 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: November 15, 2024
• First Posted: November 20, 2024
• Study Start: January 23, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)