CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Severe Renal Impairment

NCT07585760 | Recruiting Phase 2

• 1 other identifier: IIT2026037
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, single-arm, open-label, Phase II interventional clinical trial designed to evaluate the efficacy and safety of a CM336 and isatuximab regimen in patients with newly diagnosed multiple myeloma (NDMM) accompanied by severe renal impairment (\[eGFR\] \< 30 mL/min). Enrolled subjects will receive three consecutive cycles of induction therapy with CM336 in combination with isatuximab.

Conditions

Multiple Myeloma (MM); Multiple Myeloma Light Chain Induced Renal Insufficiency

Keywords

BCMA/CD3 bispecific antibody; CM336; Multiple Myeloma With Severe Renal Impairment

Outcome Measures

Primary Outcomes (1)

• Overall Renal Response Rate (Minor Response or better)

  The Overall Renal Response Rate is defined as the percentage of participants who achieve a renal response of Minor Response or better (including Minor Response, Partial Response, and Complete Response) according to the International Myeloma Working Group (IMWG) criteria for renal impairment.

  At the end of Cycle 3 (each cycle is 28 days)

Secondary Outcomes (6)

• Hematological Overall Response Rate (ORR)

  From the first dose of CM336 through 30 days after the last dose of CM336

• MRD Negativity Rate

  At the end of Cycle 3 (each cycle is 28 days)

• Kinetics of Serum Free Light Chain (sFLC) Reduction

  From the first dose of CM336 through 30 days after the last dose of CM336

• Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From the first dose of CM336 through 30 days after the last dose of CM336.

• PFS

  From the first dose of CM336 up to the date of first documented disease progression or death, up to approximately 24 months.

Study Arms (1)

CM336 plus Isatuximab

EXPERIMENTAL

Enrolled patients will receive 3 cycles of induction therapy with CM336 in combination with isatuximab.

Drug: CM336 Plus Isatuximab

Interventions

CM336 Plus Isatuximab DRUG

CM336: Administered subcutaneously (SC) via a step-up dosing regimen, which includes a step-up dosing phase and a target dosing phase. Upon reaching the target dose, it will be administered once weekly. Isatuximab: Administered intravenously (IV) at a dose of 10 mg/kg, given weekly during Cycle 1, and every two weeks during Cycles 2 and 3.

CM336 plus Isatuximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years.
• Newly diagnosed symptomatic multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) criteria. Patients who have received up to 1 cycle of prior anti-myeloma therapy, excluding immunotherapeutic agents, are allowed to enroll.
• Presence of measurable disease at diagnosis, meeting at least one of the following criteria:
• A.Serum M-protein ≥ 1 g/dL (\> 10 g/L) measured by serum protein electrophoresis (SPEP) (for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead); OR
• B.Urine M-protein ≥ 200 mg/24 hours; OR
• C.If both serum and urine M-protein do not meet the above criteria, an abnormal serum free light chain (FLC) ratio (normal FLC ratio: 0.26 to 1.65) with an involved serum FLC level ≥ 100 mg/L.
• Accompanied by myeloma-related renal impairment (RI), defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula). The type of renal impairment must be restricted to cast nephropathy, which can be confirmed by renal biopsy or by the investigator's clinical judgment based on light chain proteinuria. If urine albumin accounts for more than 30% of the total urine protein, a renal biopsy is mandatory to confirm cast nephropathy.
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
• Adequate major organ function, meeting the following criteria:
• A. Hematological function:
• Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L, and without receiving granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days, or pegylated G-CSF within 14 days prior to testing;
• Hemoglobin ≥ 60 g/L, and without receiving whole blood or red blood cell transfusions within 7 days prior to testing;
• Platelet count ≥ 50 × 10\^9/L, and without receiving whole blood, platelet transfusions, or thrombopoietin receptor agonists (TPO-RAs) within 7 days prior to testing.
• B. Hepatic function:
• Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 × ULN, and total bilirubin ≤ 2 × ULN (subjects with a history of Gilbert's syndrome are eligible if direct bilirubin ≤ 2.0 × ULN).

You may not qualify if:

• Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis, or secondary plasma cell leukemia.
• Central nervous system (CNS) involvement or clinical evidence of meningeal involvement.
• Severe and/or uncontrolled cardiac diseases, including: unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, severe and uncontrolled arrhythmias; or other cardiovascular/cerebrovascular diseases deemed unsuitable for study participation by the investigator.
• Presence of active infections, including: HIV positive; active Hepatitis B (HBV-DNA positive); active Hepatitis C (HCV-RNA positive); active or latent syphilis infection (Treponema pallidum antibody positive); active tuberculosis (active TB infection indicated by chest imaging or other relevant tests within the past 3 months or during the screening period); or other active infections deemed unsuitable for study participation by the investigator.
• Patients with concurrent malignancies; or severe concomitant diseases that, in the investigator's judgment, would severely compromise patient safety or interfere with study completion.
• Pregnant or lactating women.
• History of severe allergic reactions (Grade ≥ 3) or hypersensitivity to any components of the study drugs.
• Unable or unwilling to sign the informed consent form.
• Any other conditions that, in the opinion of the investigator, make the patient unsuitable for enrollment.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, 300000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Gang An, PhD & MD

CONTACT

+86 13502181109; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 14, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

CN (1)