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CM336

Phase 3Small molecule

KKeymed Biosciences Co.Ltd

CM336 is one of 144 small molecule programs targeting POEMS syndrome. It is currently in Phase 3.

10

Indications

13

Total Trials

13

Active Trials

143

Competitors

Pipeline

Status by Indication[3][1]

Indication

POEMS SyndromeRecruiting

AmyloidosisRecruiting

Multiple MyelomaNot yet recruiting

Immune ThrombocytopeniaRecruiting

Relapsed or RefractoryRecruiting

Multiple Myeloma (MM)Recruiting

ImmuneRecruiting

High-Risk Smoldering Multiple MyelomaRecruiting

Bispecific AntibodyNot yet recruiting

Autoimmune Bullous DiseaseRecruiting

POEMS SyndromePhase 2

Recruiting

AmyloidosisPhase 2

Recruiting

Multiple MyelomaPhase 3

Not yet recruiting

Immune ThrombocytopeniaPhase 2

Recruiting

Relapsed or RefractoryPhase 2

Recruiting

Multiple Myeloma (MM)Phase 2

Recruiting

ImmunePreclinical

Recruiting

High-Risk Smoldering Multiple MyelomaPreclinical

Recruiting

Bispecific AntibodyPhase 1

Not yet recruiting

Autoimmune Bullous DiseasePhase 2

Recruiting

Competition

Competitive Landscape

258 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Belamaf

TALVEY

Johnson & Johnson

Sarclisa

AAzienda U.S.L. 1 di Massa e Carrara

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Etentamig

Opioid

Johnson & Johnson

Adriamycin

HHRYZ Biotech Co.

CM336

KKeymed Biosciences Co.Ltd

SCTC21C

SSinocelltech Ltd.

Alnuctamab

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Immune Thrombocytopenia

NCT06799611

Q4 2027

Phase 2Recruiting

POEMS Syndrome

NCT07115654

Q1 2028

Phase 2Recruiting

Autoimmune Bullous Disease

NCT06900010

Q2 2028

Phase 1Not yet recruiting

Bispecific Antibody

NCT07407010

Clinical

Trials by Indication[1]

Multiple Myeloma (MM)3 trials

A Randomized, Open-Label, Multicenter, Phase 3 Study To Compare the Efficacy and Safety of CM336 + CM313 Combination Therapy Versus Daratumumab + Pomalidomide +Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy

Not yet recruiting·KKeymed Biosciences Co.Ltd·Phase 3·NCT07910903·320 enrolled

A Prospective, Single-arm, Single-center, Phase II Study of BCMA/CD3 Bispecific Antibody Combined With CD38 Monoclonal Antibody in Newly Diagnosed Multiple Myeloma Patients With Renal Impairment

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07585760·26 enrolled

A Phase Ib/II, Non-Randomized, Biomarker-Stratified Umbrella Study of Chemotherapy-Free Strategies in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Status: Sonrotoclax and a BCMA/CD3 Bispecific Antibody (AL-005)

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07687004·50 enrolled

Multiple Myeloma2 trials

Study of CM336 in Relapsed or Refractory Multiple Myeloma Patients

Not yet recruiting·KKeymed Biosciences Co.Ltd·Phase 3·NCT07181239·280 enrolled

A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07830485·24 enrolled

Amyloidosis1 trial

Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis

Recruiting·KKeymed Biosciences Co.Ltd·Phase 2·NCT07039578·90 enrolled

Bispecific Antibody1 trial

BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1·NCT07407010·10 enrolled

Immune Thrombocytopenia1 trial

An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06799611·20 enrolled

5 more indications

Relapsed or Refractory1 trial

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia

Recruiting·KKeymed Biosciences Co.Ltd·Phase 1/2·NCT07175493·158 enrolled

Autoimmune Bullous Disease1 trial

An Open-label, PhaseⅡ Study to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults With Moderate to Severe Autoimmune Bullous Disease

Recruiting·SShandong First Medical University·Phase 2·NCT06900010·70 enrolled

POEMS syndrome1 trial

A Prospective Single-Arm Clinical Trial of BCMA/CD3 BsAb Therapy for POEMS Syndrome

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07115654·10 enrolled

Plasma Cell Leukemia (PCL)1 trial

A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Isatuximab, Lenalidomide, and Bortezomib in Newly Diagnosed Primary Plasma Cell Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07652905·24 enrolled

High-risk Smoldering Multiple Myeloma1 trial

A Prospective, Multi-center, Single-arm Clinical Trial of BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT06745687·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for CM336. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — CM336 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for CM336. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Keymed Biosciences Co.Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: KKeymed Biosciences Co.Ltd

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