A Clinical Study of SHR-9539 in Patients With Multiple Myeloma

NCT06484777 | Recruiting Phase 1

• 1 other identifier: SHR-9539-101
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• RP2D of SHR-9539 injection

  Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma.

  Approximately 24 months

Secondary Outcomes (4)

• Incidence and severity of AE

  Up to follow-up period, approximately 24 months

• Cmax

  Up to follow-up period, approximately 24 months

• Tmax

  Up to follow-up period, approximately 24 months

• Overall Response Rate (ORR)

  Up to follow-up period, approximately 24 months

Study Arms (1)

SHR-9539 for injection

EXPERIMENTAL

Drug: SHR-9539 for injection

Interventions

SHR-9539 for injection DRUG

SHR-9539 for dose escalation/dose extension

SHR-9539 for injection

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years on day of signing the Informed Consent Form;
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
• Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria ；
• Have a life expectancy of at least 3 months；
• Male and female subjects with fertility must agree to use efficient contraceptive measures with their partners within 3 months after the last administration of the test drug from the time of signing the informed consent form, and have no fertility plan and avoid donating sperm / eggs. The pregnancy test during the screening period must be negative.

You may not qualify if:

• Central nervous system (CNS) involvement of MM；
• Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
• Prior Grade 3 or higher CRS (Per ASTCT standards) related to any T cell redirection (eg, CD-3 redirection technology or CAR-T cell therapy).
• Have other factors that may force the termination of the study, e.g., non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory abnormalities, associated family or social factors, which would affect the safety of the subjects or the collection of data and samples, as determined by the investigator.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Injections

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yang Wu

CONTACT

0518-82342973; yang.wu.yw96@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CN (1)