A Phase 1/2 interventional study of CM336 Injection in Autoimmune Cytopenia, Immune Thrombocytopenia (ITP) and Autoimmune Hemolytic Anemia, sponsored by Keymed Biosciences Co.Ltd. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Keymed Biosciences Co.Ltd · Phase 1/2, Interventional, and Treatment
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Among 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China — 82 open to participants now, 92 under way, 12 of them phase 3. Purpura, Thrombocytopenic, Idiopathic · China.
Among the 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China, this one is the 32nd largest by planned enrollment of the 167 interventional ones that give a count, is one of 27 that started in 2025, is one of 10 in phase 1/2, reaches primary completion later than 73 of the 91 other live ones, and was the 163rd registered.
504 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 159 are open to participants now.
Browse Purpura, Thrombocytopenic, Idiopathic studies →82 of the 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China are open now. Recruiting first, the newest first:
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18–75
Hangzhou Sumgen Biotech Co., Ltd. · Sites in China
Ages 18–75
Chinese SLE Treatment And Research Group · Sites in China
Ages 18–65
Shandong University · Sites in China
Ages 18–80
The First Affiliated Hospital of Soochow University · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 103 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 49 (48%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
185 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 30 · Phase 2 79 · Phase 3 43 · Phase 4 16
First in 2005; this study’s year is marked. 27 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 158 is above the median of 58 across 377 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Median enrollment 62 across the 167 interventional studies, 400 across the 18 observational. Of the 44 that completed or were terminated, 8 (18%) have results posted.
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49 of 185 have an industry lead sponsor. The 10 most frequent:
Keymed Biosciences Co.Ltd is the lead sponsor of 68 studies on the registry; 34 are open to participants now.
Keymed Biosciences Co.Ltd has 2 studies filed under Purpura, Thrombocytopenic, Idiopathic — fewer than ten, so there is no comparison to draw.
26 of the studies in Purpura, Thrombocytopenic, Idiopathic with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06900920Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia | 2027-03 |
| NCT07559331Phase 3Shandong UniversityHigh-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia | 2027-04-08 |
| NCT07657793Phase 3Chinese SLE Treatment And Research GroupSirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia | 2027-09-30 |
| NCT04812925Phase 3argenxA Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | 2027-10 |
| NCT06107582Institute of Hematology & Blood Diseases Hospital, ChinaLongitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP) | 2026-12 |
Add all 26 to your calendar (.ics) → With an account.
Among the 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: CM336 Injection
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed by monitoring the incidence, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), graded according to NCI CTCAE v5.0 and American Society for Transplantation and Cellular Therapy(ASTCT) criteria. Dose interruptions, modifications, or discontinuations due to toxicity will also be recorded.
Time frame: 52 weeks
Efficacy of CM336
Overall hematological response rate within 8 weeks
Time frame: 8 weeks
Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.
Proportion of ITP subjects with a platelet count ≥ 50 × 10\^9/L at least twice during the visit.
Time frame: up to 52 weeks.
Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.
Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.
Time frame: up to 52 weeks.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: CM336
Purpura, Thrombocytopenic, Idiopathic →