Thrombocytopenic Purpura, ImmunePhase 1NCT07622329
A Clinical Study to Evaluate JCXH-213 in the Treatment of Adults With Primary Immune Thrombocytopenia
A Phase 1 study testing JCXH-213 in people with Thrombocytopenic Purpura, Immune, run by The General Hospital of Western Theater Command.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thrombocytopenic Purpura, Immune
- What is being tested?
- JCXH-213
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 18 Jun 2026to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Failure (ineffective, loss of maintenance of response, or relapse) of corticosteroid therapy and failure (ineffective, loss of maintenance of response, or relapse) or intolerance to at least one second-line ITP therapy.
- 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).
- Ineffectiveness is defined as platelet count < 30 × 10⁹/L after receiving the following treatments:
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- Rituximab: 375 mg/m² once weekly for 4 doses; rhTPO: 300 U/kg/day for more than 14 days; Eltrombopag: 75 mg/day for more than 28 days; Hetrombopag: 7.5 mg/day for more than 28 days; Avatrombopag: 60 mg/day for more than 28 days; Romiplostim: up to a maximum weekly dose of 10 μg/kg for more than 28 days.
- 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).
- 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:
- Coagulation function:
- Activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal (ULN) Prothrombin time (PT) ≤ 1.5 × ULN
- Liver function:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN Total bilirubin ≤ 1.5 × ULN, unless documented Gilbert's syndrome Patients with Gilbert-Meulengracht syndrome may be included if total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN
- Renal function:
- Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula; see Appendix 1)
- Hematology (without blood transfusion, platelet transfusion, or growth factor use within 7 days prior to screening hematology assessment):
- Hemoglobin ≥ 80 g/L Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L Absolute lymphocyte count (LY) ≥ 0.5 × 10⁹/L
- Cardiopulmonary function:
- Left ventricular ejection fraction (LVEF) ≥ 45% Oxygen saturation ≥ 91% without supplemental oxygen
- Female patients of childbearing potential must have a negative pregnancy test at screening. Any male or female patient of childbearing potential must agree to use effective contraceptive methods from the time of signing the ICF through at least 6 months after the last infusion of JCXH-213.
- Female patients not of childbearing potential must meet at least one of the following criteria:
- Have undergone hysterectomy, bilateral salpingectomy, or bilateral oophorectomy; Medically confirmed postmenopausal (at least 12 consecutive months of amenorrhea without pathological or physiological cause, with reproductive status assessed by hormone levels if necessary).
Who cannot join
- 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.
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- 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.
- Any unstable systemic disease, including but not limited to: uncontrolled active infection (excluding local infection); unstable angina pectoris; cerebrovascular accident or transient ischemic attack (within 6 months prior to screening); myocardial infarction or history of coronary angioplasty or stenting (within 6 months prior to screening); New York Heart Association (NYHA) Class III or IV cardiac insufficiency; refractory hypertension (defined as blood pressure not controlled after more than 1 month of treatment with ≥ 3 antihypertensive drugs [including diuretics] at reasonable and tolerable doses after lifestyle modification, or requiring ≥ 4 antihypertensive drugs to achieve blood pressure control); severe cardiac arrhythmia requiring medication; or significant hepatic, renal, or metabolic disease.
- Known or suspected history of immunosuppression, including invasive opportunistic infections such as histoplasmosis, coccidioidomycosis, coccidiosis, Pneumocystis jirovecii pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections, as judged by the investigator.
- Positive peripheral blood test for hepatitis B virus (HBV) DNA; positive hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; or positive Treponema pallidum test.
- Prior receipt of organ transplantation, or planned organ transplantation during the study period.
- Prior receipt of CAR-T therapy within 3 months.
- Active autoimmune or inflammatory neurological disorder (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis).
- Clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome).
- Life expectancy of less than 3 months.
- Participation in another interventional clinical study and receipt of investigational drug within 1 month prior to enrollment (for marketed drugs, or investigational drugs with a known half-life, the shorter of 5 half-lives or 2 weeks applies).
- Receipt of live attenuated vaccine within 6 weeks prior to screening, or planned receipt of live attenuated vaccine during the study period.
- Contraindication or hypersensitivity to tocilizumab; contraindication or hypersensitivity to any component of the investigational product, JCXH-213.
- Pregnant or lactating women, or women planning to become pregnant or breastfeed from the time of signing the ICF through 6 months after the last infusion of JCXH-213; or male patients whose partner plans to become pregnant during this period.
- Any contraindication to any study procedure or other medical condition that, in the investigator's judgment and/or according to clinical standards, would place the patient at unacceptable risk.
About this study
Official title: An Open-label, Single-arm, Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of JCXH-213 in the Treatment of Adults With Primary Immune Thrombocytopenia
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.
- Conditions
- Thrombocytopenic Purpura, Immune
- Being tested
- JCXH-213
- Keywords
- JCXH-213, ITP, Primary Immune Thrombocytopenia (ITP) Refractory or Relapsed to Corticosteroids and Second-line Therapies
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCXH-213Drug
An mRNA-LNP based in vivo CAR therapy
| Study group | Role | What they receive |
|---|---|---|
| Dose Level (2 mg,4 mg) | Experimental | Not described Receives: Drug: JCXH-213 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of JCXH-213
Number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory tests results, abnormal electrocardiogram (ECG) readings, and abnormal vital signs
Measured: The DLT observation period is 14 days after the first infusion of JCXH-213 (Day1-Day14).
Secondary outcomes (11)
Platelet count over time
Platelet count measured at Weeks 1, 2, 4, 8, and Months 3 and 4 after the first JCXH-213 infusion. If platelet count remains ≥ 30 × 10⁹/L at Month 4, extended follow-up may be performed at the investigator's discretion.
Measured: Baseline to Month 4 (or longer at investigator's discretion)
Time to platelet response
Time from first JCXH-213 infusion to first platelet count ≥ 30 × 10⁹/L with ≥ 2-fold increase from baseline, and time to first platelet count ≥ 50 × 10⁹/L.
Measured: From first infusion to Day 120
Cumulative weeks of platelet response
Cumulative weeks with platelet count ≥ 30 × 10⁹/L and ≥ 2-fold increase from baseline, and cumulative weeks with platelet count ≥ 50 × 10⁹/L, from first infusion to Day 120.
Measured: From first infusion to Day 120
Change in WHO bleeding score
Change in World Health Organization (WHO) bleeding score from baseline to Day 56. The WHO bleeding score ranges from 0 to 4, with higher scores indicating worse bleeding outcomes.
Measured: Baseline to Day 56
Degree of disease control
Degree of disease control, defined as cumulative weeks with platelet count ≥ 50 × 10⁹/L over a specified period.
Measured: From first infusion to Day 120
Changes in platelet autoantibodies
Changes in platelet autoantibodies after JCXH-213 infusion, including: (1) quantitative detection of platelet surface-associated immunoglobulins (IgA, IgG, IgM); and (2) qualitative detection of platelet-specific and histocompatibility antibodies.
Measured: From first infusion to Day 120
Peripheral blood B-cell subset profiling
Peripheral blood B-cell subset distribution after JCXH-213 infusion, assessed by flow cytometry.
Measured: From first infusion to Day 120
Changes in peripheral blood JCXH-213 mRNA levels
Changes in peripheral blood JCXH-213 mRNA levels after JCXH-213 infusion, assessed by quantitative PCR (qPCR)
Measured: From within 1 hour before the first dose to 24 hours after the last dose (Day 14)
Changes in peripheral blood CD19 CAR-positive cells
Subset distribution and level changes of peripheral blood CD19 CAR-positive cells after JCXH-213 infusion, assessed by flow cytometry
Measured: From within 1 hour before the first dose to 24 hours after the last dose (up to Day 14)
Changes in peripheral blood cytokine levels
Changes in peripheral blood cytokine levels, including interleukin-6 (IL-6), interferon-α (IFN-α), and interferon-γ (IFN-γ), after JCXH-213 infusion
Measured: From within 1 hour before the first dose to 24 hours after the last dose (up to Day 14)
Changes in anti-drug antibodies (ADA)
Changes in peripheral blood anti-drug antibodies (ADA), including anti-CAR antibodies and anti-PEG antibodies, after JCXH-213 infusion
Measured: From within 1 hour before the first dose to 24 hours after the last dose (up to Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start18 Jun 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenic Purpura, ImmuneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Wang, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622329
- Sponsor's protocol ID
- JCXH-213-005
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of JCXH-213 in the Treatment of Adults With Primary Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07622329
- Acronym / sponsor ID
- JCXH-213-005
- Conditions
- Thrombocytopenic Purpura, Immune
- Keywords
- JCXH-213, ITP, Primary Immune Thrombocytopenia (ITP) Refractory or Relapsed to Corticosteroids and Second-line Therapies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Level (2 mg,4 mg) | Experimental | Drug: JCXH-213 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- Failure (ineffective, loss of maintenance of response, or relapse) of corticosteroid therapy and failure (ineffective, loss of maintenance of response, or relapse) or intolerance to at least one second-line ITP therapy.
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JCXH-213An mRNA-LNP based in vivo CAR therapy | Drug | Dose Level (2 mg,4 mg) |
Primary outcome
Safety and tolerability of JCXH-213
Time frame: The DLT observation period is 14 days after the first infusion of JCXH-213 (Day1-Day14).
Number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory tests results, abnormal electrocardiogram (ECG) readings, and abnormal vital signs
11 secondary outcomes
Platelet count over time
Time frame: Baseline to Month 4 (or longer at investigator's discretion)
Time to platelet response
Time frame: From first infusion to Day 120
Cumulative weeks of platelet response
Time frame: From first infusion to Day 120
Change in WHO bleeding score
Time frame: Baseline to Day 56
Degree of disease control
Time frame: From first infusion to Day 120
Changes in platelet autoantibodies
Time frame: From first infusion to Day 120
Peripheral blood B-cell subset profiling
Time frame: From first infusion to Day 120
Changes in peripheral blood JCXH-213 mRNA levels
Time frame: From within 1 hour before the first dose to 24 hours after the last dose (Day 14)
Changes in peripheral blood CD19 CAR-positive cells
Time frame: From within 1 hour before the first dose to 24 hours after the last dose (up to Day 14)
Changes in peripheral blood cytokine levels
Time frame: From within 1 hour before the first dose to 24 hours after the last dose (up to Day 14)
Changes in anti-drug antibodies (ADA)
Time frame: From within 1 hour before the first dose to 24 hours after the last dose (up to Day 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JCXH-213 in people with Thrombocytopenic Purpura, Immune, run by The General Hospital of Western Theater Command.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of JCXH-213 (time frame: The DLT observation period is 14 days after the first infusion of JCXH-213 (Day1-Day14).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.