A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymph… (NCT06730932) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy
China31 participantsStarted 2025-10-30
Plain-language summary
This study is A prospective，single arm, multicenter clinical study of BTLA monoclonal antibody JS004 (B/T lymphocyte attenuator factor monoclonal antibody) in combination with toripalimab in patients with unresectable or advanced renal cell carcinoma who had failed previous immunotherapy Subjects will receive JS004（B/T lymphocyte attenuator factor monoclonal antibody） plus Toripalimab until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators(continuous treatment for up to 2 years).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have fully understood and voluntarily signed the Informed Consent Form (ICF);
. 18-75 years old (at the time of signing the informed consent form); No gender restrictions; ECOG PS score: 0-1 points;
. Renal cell carcinoma with clear cell components confirmed by histology or cell pathology, including metastatic renal cell carcinoma mainly composed of clear cell components;
. Previous treatment history of the subject: Patients who have received 1-2 systemic treatments containing immunotherapy and have experienced disease progression or intolerance;
. Confirm the presence of at least one measurable lesion according to RECIST 1.1 criteria;
. Agree to provide sufficient previously stored tumor tissue specimens or agree to undergo biopsy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Blood routine examination standards (corrected for no blood transfusion or use of hematopoietic stimulating factor drugs within 2 weeks before the first trial medication):
. Hemoglobin (HGB) ≥ 90g/L;
Exclusion criteria
. History of malignant tumors other than the research disease within the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell carcinoma, or radical surgery for ductal carcinoma in situ);
. Four weeks before the first study medication, receive systemic treatment with other anti-tumor drugs (if it has a half-life of five, it can be included in the group), or receive local anti-tumor treatment, or receive clinical investigational drug or device treatment;
. Received immunotherapy within 4 weeks prior to the first study medication;
. Have undergone major surgery (as determined by the investigator) or are in the recovery period within 4 weeks prior to the first trial administration;
. Patients who have previously received treatment with anti BTLA or anti HVEM antibodies;
. Have a history of severe drug allergies, including but not limited to antibody drugs;
. Patients with contraindications for immunotherapy restart: a) grade 2-4 immune myocarditis; b) Severe grade 4 proteinuria; c) Severe or life-threatening grade 4 immune hepatitis; d) Severe grade 3-4 immune pneumonia; e) Severe inflammatory arthritis that significantly affects daily life or quality of life; f) Severe neurological toxicity: grade 2-4 myasthenia gravis; Any level of Guillain Barr é syndrome (GBS) or transverse myelitis; Grade 2-4 encephalitis; g) Severe or life-threatening grade 3-4 pancreatitis; h) Serious or life-threatening bullous diseases (grades 3-4); i) Severe grade 3-4 uveitis or episcleritis;
. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, or requiring long-term treatment with corticosteroids;