RecruitingPhase 1/2

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

China75 participantsStarted 2025-01-03

Plain-language 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). 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Safety and tolerability of CID-103

Timeframe: 10 months

Platelet response

Timeframe: 12 weeks

Trial details

NCT IDNCT07017725

SponsorCASI Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Aaron Yang

+86 01 65618789 aarony@casi.cn

View on ClinicalTrials.gov More Chronic Immune Thrombocytopenia trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

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

✓. 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.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria