A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Participants with Chronic Hepatitis B Infection- Part D
Bluejay Therapeutics, Inc
90 participants
Oct 6, 2025
Interventional
Conditions
Summary
This is a Phase 2 study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod +Nivolumab+ BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. The study consists of four parts (Part A, Part B, Part C and Part D). Part D will enroll up to 90 participants. 15 to 30 participants per cohort across 3 possible cohorts.
Eligibility
Inclusion Criteria26
- Male or female adults between 18 and 65 years of age, inclusive
- Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
- Taking a commercially available nucleos(t)ide analogs for at least 2 months prior to Screening, and willing to remain on stable treatment for the duration of the study, unless they achieve nucleos(t)ide stopping criteria.
- HBV DNA less than 100 IU/mL in blood at Screening
- HBsAg at Screening:
- a. Part D: >LLOQ to 3000 IU/mL. The upper limit of 3000 IU/mL may be removed based on emerging data.
- a. Presence of anti-thyroid antibodies (anti-thyroid-stimulating hormone receptor, anti-thyroglobulin [TG], or anti- thyroid peroxidase [TPO])
- b. Abnormal thyroid stimulating hormone
- c. Anti-nuclear antibody greater than 1:160
- d. ALT or aspartate aminotransferase (AST) greater than 2× upper limit of normal (ULN)
- e. Total bilirubin greater than 1.2× ULN, except for participants with Gilbert’s (normal direct bilirubin)
- f. Serum albumin less than .5 g/dL
- g. International normalized ratio (INR) greater than 1.2
- h. Platelet count less than 140 K/mm3
- i. Hemoglobin less than 12.0 g/dL for males and <11.0 g/dL for females
- j. Absolute neutrophil count less than 1000/mm3
- k. Estimated glomerular filtration rate less than 50 mL/min/1.73 m2 by Cockcroft-Gualt
- 12-lead electrocardiogram (ECG) showing the following: having a corrected QTc interval greater than 450 msec for males and greater than 470 msec for females or <340 msec (Fridericia’s correction)
- Clinically significant medical history of:
- a. Cardiac diseases (e.g., myocardial infarctions, stroke, arrhythmia, heart failure, and coronary heart disease)
- b. Autoimmune diseases (e.g., lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis, thyroiditis), or
- c. Malignancies within 3 years. Malignancy that has been successfully surgically resection and considered cured would not exclude the participant
- Treatment with an investigational drug, biological agent or device within 4 weeks or 5 half-lives prior to Screening, whichever is longer.
- History of excess alcohol consumption within 1 year of Screening, defined as weekly intake of greater than or equal to 14 drinks per week (average of greater than or equal to 2 drinks per day)
- History of drug abuse/addiction within 6 months of Screening (except cannabis)
- Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the investigator would make the participant unsuitable for inclusion, or could interfere with the individual participating in or completing the study
Exclusion Criteria11
- Pregnant or nursing females
- Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study
- Fibroscan greater than or equal to 8.5 kPa within 1 year of Screening
- History of and/or current decompensated liver disease as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal variceal bleeding
- Presence of liver disease, not including chronic HBV infection, such as nonalcoholic steatohepatitis (NASH), alcohol-associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HDV) or non-viral hepatitis that has the potential to impact interpretation
- of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated greater than or equal to 6 months prior to Screening.
- Positive for HIV, HDV, or HCV infection at Screening
- Received solid organ or bone marrow transplant
- Chronic systemic immunosuppressive therapy (e.g., prednisone) within 1 month of Screening or require the use of during the study.
- Prior or current history of hepatocellular carcinoma (HCC) or suspected HCC as evidenced by screening alpha-fetoprotein greater than or equal to 20 ng/mL
- History of hypersensitivity to any of the components in the cavrotolimod, BJT-778 or nivolumab formulation components or severe reactions to injections
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Interventions
Investigational Product (IP): Cavrotolimod, Nivolumab and BJT-778 Dosage Form: Vial Method of administration: Sub cutaneous injection (SC) Dose: Cavrotolimod will be supplied as 2mL vial; Nivolumab will be supplied as 4mL vial and BJT-778 will be supplied as 6 mL glass vial. This study consists of 4 parts (Part A, B, C and D). This registration is for Part D. Part D will evaluate up to 48-week combination regimen(s) with cavrotolimod ± BJT-778 ± lowdose nivolumab for the treatment of Chronic Hepatitis B infection (CHB). The open-label combination regimens(s) to be tested in Part D will be confirmed by the SRC based on review of emerging safety, tolerability, antiviral activity, and PK/PD, including BJT-008-001 Part B (ACTRN12624000809538) and Part C and BJT-778-001 evaluating BJT-778 900 mg administered SC every 4 weeks in combination with low-dose nivolumab 0.3 mg/kg IV at Week 4 and 24. This will include review of 8-week safety data from BJT-008-001 Part B, 4week safety data from BJT-008-001 Part C, and 24-weeks of safety data from BJT-778-001 Cohort G (New protocol in development with BJT-778 and Nivolumab). The combination regimen(s) will not exceed a total duration of 48 weeks. The difference between these cohorts will be determined by the SRC at the time of opening. Cohorts 2 and 3 are optional cohorts and may open upon SRC decision. • Cohort 1, Arm 1 and Expansion Arm 1a will receive Cavrotolimod (less than equal to 24 mg) SC ± BJT-778 900 mg SC every 4 weeks ± low-dose nivolumab (0.3 mg/kg) every 3 months for up to 48 weeks • Optional Cohort 2, Arm 1 and Expansion Arm 1a will receive Cavrotolimod (less than equal to 24 mg) SC ± BJT-778 900 mg SC every 4 weeks ± low-dose nivolumab (0.3 mg/kg) every 3 months for up to 48 weeks • Optional Cohort 3, Arm 1 and Expansion Arm 1a will receive Cavrotolimod (less than equal to 24 mg) SC ± BJT-778 900 mg SC every 4 weeks ± low-dose nivolumab (0.3 mg/kg) every 3 months for up to 48 weeks Participants will be followed for 24 weeks after the last dose of study medications. Participants who achieve HBsAg loss (HBsAg <LLOQ) at the end of follow up will continue to be followed for an additional 24 weeks (total 48 weeks of follow up). Part D may not start until after review of the 4-week safety data from Part C. Interim safety, tolerability and available efficacy data will be reviewed by the SRC when the first =5 participants in a cohort A have completed 12 weeks of treatment and 24 weeks of treatment. The SRC can recommend modification to study medication or safety monitoring, discontinue a treatment arm, or discontinue the study. Additional cohorts may also be initiated based on the emerging data and SRC recommendation. The selected dose(s), regimen(s), and combination(s) to be evaluated in Part D will be agreed upon by the SRC.
Locations(6)
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ACTRN12625000173493