DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs

NCT06329908 | Recruiting Early Phase 1 DMC

• 1 other identifier: TSLG-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.

Conditions

Lung Cancer

Keywords

Criteria for inclusion

Outcome Measures

Primary Outcomes (1)

• The safety of Neo-DCVac combined with ICIs.

  This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by" CTCAE v5.0".

  2 years

Secondary Outcomes (2)

• The efficacy of Neo-DCVac combined with ICIs.

  2 years

• The efficacy of Neo-DCVac combined with ICIs.

  2 years

Other Outcomes (1)

• Synergistic anti-tumor mechanism.

  2 years

Study Arms (1)

(Neo-DCVac) combined with immune checkpoint inhibitors (ICIs)

EXPERIMENTAL

DC cell injection ,1.5 × 10 7/time, subcutaneous multi-point injection in axilla and groin or lymph node injection guided by color Doppler ultrasound in axilla and groin, continuous injection at 0W, 1W, 3W, 5W and 7W for five times as the first immunization cycle. Tumor response was evaluated 2 weeks after the completion of the first immunotherapy cycle, and treatment was continued if the response was evaluated as effective (SD/PR/CR), and every 3 weeks until disease progression or intolerable toxicity or active withdrawal of the patient, whichever came first.ICIs are PD1/PD-L1 inhibitors and continue to be pre-enrollment ICIs of any brand

Drug: LG002

Interventions

LG002 DRUG

Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.

Also known as: ICIs

(Neo-DCVac) combined with immune checkpoint inhibitors (ICIs)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-85 years.
• ECOG score was 0-2.
• Histological or cytological diagnosis confirmed non-small cell lung cancer, which was staged IIIB-IV according to AJCC version 8.
• Patients have received first-line chemotherapy combined with ICIs (PD1/PD-L1, ICIs type is not limited) and developed drug resistance.
• Normal function of major organs, that is, meeting the following criteria: a) blood routine examination (hematopoietic growth factors and blood transfusion were not used within 7 days): granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥ 80 g/L; b) biochemical examination: total bilirubin ≤ 1.5 × ULN (upper limit of normal); serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) coagulation function: INR or PT ≤ 1.5 × ULN (upper limit of normal), if the subject is receiving anticoagulant therapy, as long as PT is in the range proposed by anticoagulant drugs; d) urine routine examination: urine routine examination urine protein ≥ 2 +, 24-hour urine protein quantitative examination should be performed, such as quantitative urine protein ≤ 1 g/24 h.
• Female subjects of childbearing age or male subjects with sexual partners of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months before and after the treatment period.
• Subjects voluntarily participate in the study and sign the informed consent form

You may not qualify if:

• The pathological type is mixed type, containing small cell carcinoma or other types of components.
• with the blood-borne infectious disease HIV.
• History of mental disorder, drug abuse and drug abuse.
• Any other malignancy (except completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer) within 3 years.
• Accompanied by other immune diseases, or long-term use of immunosuppressive agents or hormones.
• Any unstable systemic disease (including active uncontrolled gastrointestinal ulcers, gastric obstruction, bleeding risk or coagulopathy, active infection, for subjects with hepatitis B, anti-hepatitis B 11 virus treatment is required during study treatment, active hepatitis C subjects (HCV antibody positive and HCV- RNA levels above the lower limit of detection, grade IV hypertension, unstable angina pectoris, congestive heart failure, myocarditis, unstable cerebrovascular disease, thrombotic disease, liver, kidney, uncontrolled metabolic disease or unhealed fractures, wounds as judged by the surgeon).
• Presence of active central nervous system (CNS) metastases; subjects with previously treated brain metastases (e.g., surgery, radiotherapy, hormone therapy) are allowed if clinically stable for at least two weeks after treatment from the first dose of study drug and corticosteroids are discontinued 7 days before study drug administration; untreated, asymptomatic subjects with brain metastases (i.e., no neurological symptoms, no need for corticosteroids, no significant edema around the brain metastases) can be enrolled.
• Any anti-tumor therapy including chemotherapy, radiotherapy, and targeted therapy within 3 weeks prior to the first dose of study drug.
• Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring drainage.
• Previous use of anti-tumor vaccines, live vaccines within 30 days.
• Patients are difficult to communicate or to follow up for a long time. Pregnant or lactating women.
• Current or planned participation in other clinical trials.
• Dr. finds other unsuitable situations

Sponsors & Collaborators

• Zhen-Yu Ding: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Qing Li, MD

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Zhengyu Ding, MD

CONTACT

18980601957; dingzhenyu@scu.edu.cn

Qing Li, MD

CONTACT

18702848178; liqing@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: single arm

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: March 26, 2024
• Study Start: September 27, 2023
• Primary Completion: September 30, 2024
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)