A Study of the RNA Tumor Vaccine Targeting MICA/B in Patients With Advanced Solid Tumors

NCT06610227 | Active Not Recruiting Early Phase 1

• 1 other identifier: SapRNA-MICA/B
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm study to evaluate the safety and efficacy of multiple doses of SapRNA™-MICA/B Tumor Vaccine in patients with advanced solid tumors. Eligible patients will receive the monotherapy with SapRNA™-MICA/B Tumor Vaccine, which will be administered by intramuscular injection on Day 1, Day 14, and Day 28 respectively. Follow-up visits will be performed as scheduled after the end of treatment.

Conditions

Advanced Solid Tumors

Keywords

RNA vaccine; MICA; MICB

Outcome Measures

Primary Outcomes (1)

• adverse events

  Frequency, number, incidence, and severity of the adverse events and adverse reactions

  From enrollment to the end of treatment at 30 days

Secondary Outcomes (3)

• Objective response rate (ORR)

  Every 6 weeks from the first dose of treatment until the date of first documented progression, the start of other treatment, or date of death from any cause, whichever came first, up to 2 years

• Immunogenicity

  1 hour before injection at Day 1, Day 14, and Day 28, and then Week 7 and Week 16

• Target protein expression

  1 hour before injection at Day 1, and then Week 7 and Week 16

Other Outcomes (2)

• MICA/B-specific CD4+ and CD8+ T lymphocytes

  1 hour before injection at Day 1, and then Week 7 and Week 16

• NK cells in peripheral blood

  1 hour before injection at Day 1, and then Week 7 and Week 16

Study Arms (1)

SapRNA™-MICA/B

EXPERIMENTAL

Patients will receive the monotherapy with SapRNA™-MICA/B Tumor Vaccine, which will be administered by intramuscular injection on Day 1, Day 14, and Day 28 respectively.

Biological: SapRNA™-MICA/B Tumor Vaccine

Interventions

SapRNA™-MICA/B Tumor Vaccine BIOLOGICAL

patients will receive the monotherapy with SapRNA™-MICA/B Tumor Vaccine, which will be administered by intramuscular injection on Day 1, Day 14, and Day 28 respectively

SapRNA™-MICA/B

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years, male or female;
• Expected survival ≥12 weeks;
• Patients with advanced solid tumors as confirmed by cytology or histology who fail standard of care (progressed after treatment or intolerant to the treatment) and have no effective treatment available, or have no standard of care available, or unable to receive standard of care due to limitation of objective conditions;
• Patients with at least 1 measurable lesion as per RECIST v1.1;
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• Patients with adequate organ and bone marrow function. Definitions are as follows:
• Hematology: Absolute neutrophil count (ANC) ≥1.5×109/L; platelet count (PLT) ≥100×109/L; haemoglobin (HGB) ≥9.0 g/dL. No treatment with granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), red blood cell transfusion, and platelet transfusion within 14 days prior to the assessment.
• Liver function:
• Patients with liver metastases: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5×upper limit of normal (ULN), and total bilirubin ≤1.5×ULN (exception: for patients with Gilbert's syndrome, total bilirubin ≤3.0×ULN is acceptable if direct bilirubin ≤35%).
• Patients without liver metastases: AST and ALT ≤2.5×ULN, and total bilirubin ≤1.5×ULN (exception: for patients with Gilbert's syndrome, total bilirubin ≤3.0×ULN is acceptable if direct bilirubin ≤35%).
• Kidney function: Serum creatinine (Scr) ≤1.5×ULN;
• Adequate coagulation function: International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5×ULN; it's acceptable to enroll patients who are on anticoagulant therapy as long as the PT is within the established therapeutic range for anticoagulants;
• Left ventricular ejection fraction (LVEF) ≥50% as shown by an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan;
• Willing to sign a written informed consent form and complete the visits and related procedures as required by the protocol.

You may not qualify if:

• Patients with autoimmune disease or who are immunosuppressed; requiring treatment with systemic corticosteroids (≥10 mg prednisone, or equivalent dose of other corticosteroids) or immunosuppressants within 14 days prior to the first dose; inhaled and topical steroids are acceptable, or physiological replacement doses of steroids for adrenal insufficiency are acceptable;
• Patients who received major surgery (such as major transabdominal and transthoracic surgeries, excluding diagnostic aspiration or replacement of peripheral intravenous catheters) within 28 days prior to the first dose;
• Patients who received other antitumor therapies within 28 days prior to the first dose or 5 half-lives of the prior antitumor drug (whichever shorter);
• Female patients who are breastfeeding or have positive serum pregnancy test results at screening;
• Patients who experienced any grade 4 immune-related adverse events (irAEs) after receiving prior immunotherapy (patients with endocrine disorders may be enrolled if receiving replacement therapy or experiencing asymptomatic serum amylase and lipase increased), experienced any irAEs leading to permanent discontinuation of treatment after receiving prior immunotherapy, or experienced any grade 3 irAEs within ≤6 months prior to the dose;
• Patients known to have or diagnosed with active central nervous system (CNS) metastases and/or carcinomatous meningitis at screening. However, the following patients may be enrolled: 1) patients with asymptomatic brain metastases (i.e., without progressive CNS symptoms caused by brain metastases, nor requiring treatment with corticosteroids). 2) patients who are treated with stable brain metastases for at least 2 months, without evidence indicating new or enlarged brain metastases;
• Patients with serious cardiovascular and cerebrovascular disorders: inadequately controlled hypertension (systolic blood pressure \>160 mmHg, diastolic blood pressure \>95 mmHg) after standard of care, symptomatic cardiac insufficiency (NYHA II- IV), unstable angina or myocardial infarction within 6 months, or patients with risks of QTc interval prolongation or arrhythmia (QTcF \>470 ms at baseline, uncorrected hypokalaemia, long QT syndrome, atrial fibrillation with heart rate \>100 bpm at rest, or serious cardiac valve disease);
• Patients with uncontrolled pleural effusion, ascites, and pericardial effusion;
• Patients with active infections requiring treatment: active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection; known history of human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS); active tuberculosis, etc.;
• Patients with toxicities from prior antitumor therapies which fail to return to CTCAE grade ≤1 (NCI-CTCAE v5.0) or baseline level, excluding atrichia and skin pigmentation (any grades);
• Patients with a history of severe allergic reactions to biologics;

Sponsors & Collaborators

• NING LI: lead

Study Sites (1)

National Cancer Center

Beijing, Beijing Municipality, 100021, China

Location

Study Officials

• Ning Li, M.D.

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

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: Director of Clinical Trial Center

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 24, 2024
• Study Start: November 8, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)