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Clinical Trials in China / NCT07652281
Recruiting Phase 1

A Clinical Study of SHR-5421 in Patients With Multiple Myeloma

NCT07652281 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase
Phase 1
Started
2026-07-23
Last updated
2026-07-30

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

SHR-5421 for Injection

SHR-5421 for Injection: SHR-5421 for injection.

Study summary

This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-5421 in patients with multiple myeloma (MM).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years, male or female. 2. Expected survival ≥ 3 months. 3. ECOG performance status 0 or 1. 4. Diagnosed with active multiple myeloma per IMWG criteria. 5. Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy. 6. Disease progression or non-response to the most recent therapy. 7. Measurable disease as defined by serum/urine M-protein or serum free light chain. 8. Adequate bone marrow, hepatic, renal, and coagulation function. 9. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception. 10. Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: 1. Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome. 2. Central nervous system involvement by tumor. 3. History of ≥ Grade 3 CRS with prior T-cell redirecting therapy. 4. Requirement for dialysis or plasmapheresis within 14 days prior to study drug. 5. Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies). 6. Concurrent participation in another clinical study. 7. Prior anti-tumor therapy within specified washout periods. 8. Major surgery within 28 days prior to informed consent or planned during the study. 9. Live attenuated vaccine within 4 weeks prior to first dose or planned during the study. 10. Significant comorbidity that in the investigator's judgment would interfere with study participation or safety. 11. Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo). 12. Active infection. 13. Known hypersensitivity or contraindication to SHR-5421.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality Recruiting

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07652281 on ClinicalTrials.gov ↗ ← All trials in China