Chronic Immune ThrombocytopeniaPhase 1/2NCT07017725
A Dose-escalation Study Followed by a Dose Optimal Study to Evaluate the Safety and Efficacy of CID-103 in Adults With Chronic Immune Thrombocytopenia
A Phase 1/2 study testing CID-103 in people with Chronic Immune Thrombocytopenia, run by CASI pharmaceuticals, Inc. at 6 sites in China.
Trial summary
The goal of the global Phase 1/2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with chronic immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Immune Thrombocytopenia
- What is being tested?
- CID-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesChina
- Study dates
- 3 Jan 2025to 30 Dec 2026
- Phase
- Phase 1/2
- 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
- Male or female individuals aged 18 to 65 years at time of signing of ICF. Disease-related.
- Diagnosed with ITP that has persisted for ≥ 3 months, diagnosed in accordance with The American Society of Hematology 2019 Guidelines for Immune Thrombocytopenia or the Updated International Consensus Report on the Investigation and Management of Primary Immune Thrombocytopenia (as locally applicable).
- Diagnosis of ITP supported by a prior response to an ITP treatment (other than a thrombopoietin receptor agonists [TPO-RA]) that achieved a platelet count of ≥ 30 x 10^9/L and a doubling of baseline measurement.
- Has received at least two lines of SOC systemic treatment (i.e., corticosteroids and one other agent).
- Has a mean platelet count ≤ 35 x 10^9/L on at least two measurements at least one week apart during screening.
- If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least four weeks prior to first dose of CID-103.
- Adequate organ function.
- Contraception: Female participants must either be non-pregnant or not breastfeeding and must have a negative pregnancy test. Male and female participants must meet the contraceptive requirements.
Who cannot join
- Prior treatment with any anti-CD38 agent, or has been treated with anti-Bruton's tyrosine kinase (BTK), neonatal Fc receptor (FcRn) antagonist or complement inhibitor within three months prior to first dose of CID-103.
- Use of IV immunoglobulin, subcutaneous immunoglobulin or anti-D immunoglobulin treatment within four weeks of screening.
- Treatment with rituximab or splenectomy within the three months prior to first dose of CID-103.
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within three weeks before screening.
- Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of CID-103 or five half-lives (if shorter).
- Active hemolytic anemia.
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- Diagnosed with severe chronic obstructive pulmonary disease (COPD), Global Initiative for Chronic Obstructive Lung Disease (GOLD Stage 3 or 4) or asthma.
- Has been diagnosed with myelodysplastic syndrome or other active malignancy.
- Known / clinically significant amyloidosis.
- Has a history of any thrombotic or embolic event within six months before screening.
- A history or evidence of cardiovascular risk including left ventricular ejection fraction < 50%, clinically significant uncontrolled ventricular arrhythmia, acute coronary syndrome history, coronary angioplasty or stenting within six months, current ≥ Class III congestive heart failure (NYHA guidelines), and treatment refractory hypertension.
- Clinically significant medical history or ongoing chronic illness.
- Known active infection with hepatitis B (HBV) (surface antigen) or infection with hepatitis C (HCV) in absence of sustained virologic response.
- History of known or suspected immunosuppression.
- Known active infection with human immunodeficiency virus (HIV) and CD4+ T cell count < 350/μL.
- Karnofsky Performance Status ≤ 70.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 50000
Jun Peng, +86 0531-82168888, junpeng88@sina.com
- Not yet recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Zeping Zhou, +86 0871-65351281, zhouzeping@kmmu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Ruibin Huang, +86 0791-88692748, rbhuang69@163.com
- Recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000
Zhenyu Yan, +86 0315-5826365, hbyzy2011@163.com
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
Lei Zhang, +86 022-239099, zhanglei1@ihcams.ac.cn
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Hu Zhou, +86 400 0371 818, papertigerhu@163.com
About this study
Official title: A Dose-escalation and Safety Study of CID-103 Followed by a Randomized, Open-label, Parallel-arm Multi-dose Study Evaluating the Efficacy and Tolerability of CID-103 in Adults With Chronic Immune Thrombocytopenia
The goal of the global Phase 1/2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with chronic immune thrombocytopenia (ITP). The main questions the study aims to answer are:
- To evaluate the safety and tolerability of CID-103 in subjects with ITP with different increasing doses of CID-103.
- To further evaluate the safety and tolerability of CID-103 at two or three dose levels and to select an optimal dose and administration regimen for CID-103 for further study of clinical efficacy.
Read more
The study will be done in two parts:
Part A will test increasing doses of CID-103 to see how safe it is and how well people tolerate it. Researchers will also aim to find a safe dose range.
Part B will compare up to three different doses of CID-103 to see how well the medicine works and gather more safety and efficacy information. The goal is to find the optimal dose to use in future studies.
CID-103 is given through an intravenous (IV) infusion. During the study, participants may receive treatment for up to 6 months, followed by a post-treatment safety follow-up period to check for ongoing safety and effectiveness.
This study is an important step toward developing a new treatment for people living with chronic ITP. If CID-103 is found to be safe and effective, it could offer a new option for patients who do not respond well to current therapies.
- Conditions
- Chronic Immune Thrombocytopenia
- Being tested
- CID-103
- Keywords
- Purpura, Thrombocytopenic, Idiopathic
- Medical subject headings
- Purpura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CID-103Drug
Strength:20 mg/mL. Route of administration: IV infusion. Treatment duration: QW for 6 weeks, then at the same dose Q2W up to Week 12. If treatment continues after Week 12, dosing will occur monthly for up to a maximum treatment duration of six months.
| Study group | Role | What they receive |
|---|---|---|
| Part B (Randomized Dose Exploration) high-dose cohort | Experimental | Each participant will receive selected high-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. Receives: Drug: CID-103 |
| Part B (Randomized Dose Exploration) intermediate-dose cohort | Experimental | Each participant will receive selected intermediate-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. Receives: Drug: CID-103 |
| Part B (Randomized Dose Exploration) low-dose cohort | Experimental | Each participant will receive selected low-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. Receives: Drug: CID-103 |
| Part A (Dose Escalation) Cohort 1- 30 mg/30 mg | Experimental | This is the initial dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. Receives: Drug: CID-103 |
| Part A (Dose Escalation) Cohort 1- 30 mg/150 mg | Experimental | This is the second dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. Receives: Drug: CID-103 |
| Part A (Dose Escalation) Cohort 1- 150 mg/300 mg | Experimental | This is the third dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. Receives: Drug: CID-103 |
| Part A (Dose Escalation) Cohort 1- 150 mg/600 mg | Experimental | This is the fourth dose cohort with standard 3+3 design. Receives: Drug: CID-103 |
| Part A (Dose Escalation) Cohort 1- 150 mg/900 mg | Experimental | This is the fifth dose cohort with standard 3+3 design. Receives: Drug: CID-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CID-103
- Occurrence of DLTs (Part A only)
- Frequency of TEAEs
- Related AEs
- Grade 3/4 AEs
- Serious adverse events (SAEs)
- Fatal AEs
- AEs leading to CID-103 discontinuation up to Week 12
- Percentage of subjects with at least one treatment-related Grade ≥ 3 TEAE, SAE or AE leading to CID-103 discontinuation up to Week 12 (Part B only)
Measured: 10 months
Platelet response
A platelet count ≥ 50 x 10^9/L and ≥ 20 x 10^9/L above baseline achieved on at least two consecutive measurements at least seven days apart.
Measured: 12 weeks
Secondary outcomes (2)
Platelet count
The secondary efficacy endpoint is Platelet count, defined as platelet count ≥ 30 x 10^9/L and > 2-fold increase in platelet count from baseline and absence of bleeding requiring medical intervention / treatment, measured on at least two consecutive occasions at least seven days apart.
Measured: 12 weeks
Complete platelet response
The secondary efficacy endpoint includes percentage of subjects with complete platelet response, defined as platelet count ≥ 100 x 109/L and absence of bleeding requiring medical intervention / treatment, measured on at least two consecutive occasions at least seven days apart.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start3 Jan 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Immune ThrombocytopeniaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A (Dose Escalation and Safety Phase): This phase combines the accelerated escalation and traditional 3+3 escalation with at least five dosing cohorts designed:30 mg, 150 mg, 300 mg, 600 mg, and 900 mg. Subjects will receive an initial priming dose of either 30 mg for the first two cohorts or 150 mg for the rest of cohorts. Dose escalation to the next cohort will be determined based on safety and tolerability data. Part B (Randomized Dose Comparison Phase): This phase follows a parallel assignment model, in which participants are randomly assigned to one of three selected doses of CID-103: low, intermediate, or high. The purpose is to determine the optimal dose to advance into future studies.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junping Chen, Study chair, CASI pharmaceutical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017725
- Sponsor's protocol ID
- CASI-CID-103-201
- Other IDs
- CTR20244168
- Status last verified
- May 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation and Safety Study of CID-103 Followed by a Randomized, Open-label, Parallel-arm Multi-dose Study Evaluating the Efficacy and Tolerability of CID-103 in Adults With Chronic Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07017725
- Acronym / sponsor ID
- CASI-CID-103-201
- Conditions
- Chronic Immune Thrombocytopenia
- Keywords
- Purpura, Thrombocytopenic, Idiopathic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (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.
The goal of the global Phase 1/2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with chronic immune thrombocytopenia (ITP). The main questions the study aims to answer are:
- To evaluate the safety and tolerability of CID-103 in subjects with ITP with different increasing doses of CID-103.
- To further evaluate the safety and tolerability of CID-103 at two or three dose levels and to select an optimal dose and administration regimen for CID-103 for further study of clinical efficacy.
The study will be done in two parts:
Part A will test increasing doses of CID-103 to see how safe it is and how well people tolerate it. Researchers will also aim to find a safe dose range.
Part B will compare up to three different doses of CID-103 to see how well the medicine works and gather more safety and efficacy information. The goal is to find the optimal dose to use in future studies.
CID-103 is given through an intravenous (IV) infusion. During the study, participants may receive treatment for up to 6 months, followed by a post-treatment safety follow-up period to check for ongoing safety and effectiveness.
This study is an important step toward developing a new treatment for people living with chronic ITP. If CID-103 is found to be safe and effective, it could offer a new option for patients who do not respond well to current therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Part A (Dose Escalation and Safety Phase): This phase combines the accelerated escalation and traditional 3+3 escalation with at least five dosing cohorts designed:30 mg, 150 mg, 300 mg, 600 mg, and 900 mg. Subjects will receive an initial priming dose of either 30 mg for the first two cohorts or 150 mg for the rest of cohorts. Dose escalation to the next cohort will be determined based on safety and tolerability data. Part B (Randomized Dose Comparison Phase): This phase follows a parallel assignment model, in which participants are randomly assigned to one of three selected doses of CID-103: low, intermediate, or high. The purpose is to determine the optimal dose to advance into future studies.
| Arm | Type | Receives |
|---|---|---|
| Part B (Randomized Dose Exploration) high-dose cohort | Experimental | Drug: CID-103Each participant will receive selected high-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. |
| Part B (Randomized Dose Exploration) intermediate-dose cohort | Experimental | Drug: CID-103Each participant will receive selected intermediate-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. |
| Part B (Randomized Dose Exploration) low-dose cohort | Experimental | Drug: CID-103Each participant will receive selected low-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. |
| Part A (Dose Escalation) Cohort 1- 30 mg/30 mg | Experimental | Drug: CID-103This is the initial dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 30 mg/150 mg | Experimental | Drug: CID-103This is the second dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 150 mg/300 mg | Experimental | Drug: CID-103This is the third dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 150 mg/600 mg | Experimental | Drug: CID-103This is the fourth dose cohort with standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 150 mg/900 mg | Experimental | Drug: CID-103This is the fifth dose cohort with standard 3+3 design. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female individuals aged 18 to 65 years at time of signing of ICF. Disease-related.
- Diagnosed with ITP that has persisted for ≥ 3 months, diagnosed in accordance with The American Society of Hematology 2019 Guidelines for Immune Thrombocytopenia or the Updated International Consensus Report on the Investigation and Management of Primary Immune Thrombocytopenia (as locally applicable).
- Diagnosis of ITP supported by a prior response to an ITP treatment (other than a thrombopoietin receptor agonists [TPO-RA]) that achieved a platelet count of ≥ 30 x 10^9/L and a doubling of baseline measurement.
- Has received at least two lines of SOC systemic treatment (i.e., corticosteroids and one other agent).
- Has a mean platelet count ≤ 35 x 10^9/L on at least two measurements at least one week apart during screening.
Key exclusion criteria (16 listed)
- Prior treatment with any anti-CD38 agent, or has been treated with anti-Bruton's tyrosine kinase (BTK), neonatal Fc receptor (FcRn) antagonist or complement inhibitor within three months prior to first dose of CID-103.
- Use of IV immunoglobulin, subcutaneous immunoglobulin or anti-D immunoglobulin treatment within four weeks of screening.
- Treatment with rituximab or splenectomy within the three months prior to first dose of CID-103.
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within three weeks before screening.
- Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of CID-103 or five half-lives (if shorter).
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 |
|---|---|---|
| CID-103Strength:20 mg/mL. Route of administration: IV infusion. Treatment duration: QW for 6 weeks, then at the same dose Q2W up to Week 12. If treatment continues after Week 12, dosing will occur monthly for up to a maximum treatment duration of six months. | Drug | Part A (Dose Escalation) Cohort 1- 150 mg/300 mg, Part A (Dose Escalation) Cohort 1- 150 mg/600 mg, Part A (Dose Escalation) Cohort 1- 150 mg/900 mg, Part A (Dose Escalation) Cohort 1- 30 mg/150 mg, Part A (Dose Escalation) Cohort 1- 30 mg/30 mg, Part B (Randomized Dose Exploration) high-dose cohort, Part B (Randomized Dose Exploration) intermediate-dose cohort, Part B (Randomized Dose Exploration) low-dose cohort |
Primary outcome
Safety and tolerability of CID-103
Time frame: 10 months
* Occurrence of DLTs (Part A only) * Frequency of TEAEs * Related AEs * Grade 3/4 AEs * Serious adverse events (SAEs) * Fatal AEs * AEs leading to CID-103 discontinuation up to Week 12 * Percentage of subjects with at least one treatment-related Grade ≥ 3 TEAE, SAE or AE leading to CID-103 discontinuation up to Week 12 (Part B only)
Platelet response
Time frame: 12 weeks
A platelet count ≥ 50 x 10^9/L and ≥ 20 x 10^9/L above baseline achieved on at least two consecutive measurements at least seven days apart.
2 secondary outcomes
Platelet count
Time frame: 12 weeks
Complete platelet response
Time frame: 12 weeks
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 12 Jun 2025.
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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.
Junping Chen study chair
CASI pharmaceutical, Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CID-103 in people with Chronic Immune Thrombocytopenia, run by CASI pharmaceuticals, Inc. at 6 sites in China.
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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Aaron Yang (+86 01 65618789, aarony@casi.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of CID-103 (time frame: 10 months). The study lists 2 primary outcomes in all. 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 12 Jun 2025.