A Clinical Study to Evaluate JCXH-213 in the Treatment of Adults With Primary Immune Thrombocytop… (NCT07622329) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study to Evaluate JCXH-213 in the Treatment of Adults With Primary Immune Thrombocytopenia
4 participantsStarted 2026-06-18
Plain-language summary
This is an open-label, single-arm, dose-escalation study designed to evaluate the safety, tolerability, recommended subsequent dose, pharmacokinetic profile, and preliminary efficacy of JCXH-213 in adult patients with primary immune thrombocytopenia (ITP) who are refractory or relapsed after treatment with corticosteroids and second-line therapies.
The study consists of a screening period, treatment period, end-of-treatment visit, safety follow-up, and study withdrawal visit. Two dose groups are planned: 2 mg and 4 mg, with 2 patients to be enrolled in each dose group. During the treatment period, JCXH-213 at the assigned dose will be administered once every other day for a total of 7 doses. Assessments for safety and efficacy will be conducted according to the study schedule. After the last dose, patients will undergo an end-of-treatment visit and safety follow-up until the end of the study.
Who can participate
Age range
18 Years – 65 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
. Voluntarily sign the informed consent form (ICF) and be expected to complete the follow-up visits and treatment required by the study protocol.
. Age ≥ 18 years and ≤ 65 years at screening, male or female.
. Clinical diagnosis of primary immune thrombocytopenia (ITP) for no less than 3 months, according to the American Society of Hematology 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report on the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable.
. At least one second-line ITP therapy includes: rituximab and/or recombinant human thrombopoietin (rhTPO, e.g., TPO), thrombopoietin receptor agonists (TPO-RA, e.g., eltrombopag, hetrombopag, avatrombopag, romiplostim).
. Platelet count \< 30 × 10⁹/L within 48 hours prior to the first dose of study drug (at least two consecutive platelet counts \< 30 × 10⁹/L, at least 1 day apart, during screening and/or prior to first dose).
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.
What they're measuring
1
Safety and tolerability of JCXH-213
Timeframe: The DLT observation period is 14 days after the first infusion of JCXH-213 (Day1-Day14).
Trial details
NCT IDNCT07622329
SponsorThe General Hospital of Western Theater Command
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
. Patients receiving stable-dose maintenance therapy, including corticosteroids (not exceeding 0.5 mg/kg/day prednisone or equivalent) or thrombopoietin receptor agonists, may be enrolled, provided that the patient is on only one concomitant medication with stable dose and frequency, and the concomitant medication has been stable for at least 4 weeks prior to the first infusion of study drug.
. Adequate organ function, meeting the following laboratory criteria:
Exclusion criteria
. Diagnosis of autoimmune hemolytic anemia, any secondary or hereditary thrombocytopenic disorders, including leukemia, lymphoma, multiple myeloma, aplastic anemia, myelodysplastic syndrome, Evans syndrome, common variable immunodeficiency, systemic lupus erythematosus, liver cirrhosis, antiphospholipid syndrome, pseudothrombocytopenia, or drug-induced thrombocytopenia (e.g., due to quinine, heparin, antibiotics, or antiepileptic drugs).
. History of any thromboembolic event or extensive/severe bleeding within 1 year prior to the first dose of study drug, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or presence of sepsis or other irregular bleeding.
. Receipt of anti-CD20 monoclonal antibody (e.g., rituximab) or other medicinal treatments (including cyclophosphamide and vindesine) within 3 months prior to the first dose of study drug.
. Receipt of the following medicinal treatments within 4 weeks prior to the first dose of study drug: azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, or sirolimus.
. Use of anticoagulants or any antiplatelet agents (e.g., aspirin) within 3 weeks prior to the first dose of study drug.
. Receipt of emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin, or TPO-RA) within 2 weeks prior to the first dose of study drug.
. Splenectomy within 6 months prior to the first dose of study drug.
. History of malignancy within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery.