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

An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-5421 in Patients With Multiple Myeloma

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07652281

Enrollment

Registered

2026-06-17

Start date

2026-07-23

Completion date

2029-04-01

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief 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).

Interventions

DRUGSHR-5421 for Injection

SHR-5421 for injection.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This is a phase I, open-label, dose escalation and expansion study of SHR-5421 in patients with relapsed or refractory multiple myeloma.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Determination of Phase II Dose (RP2D) of SHR-5421	24 months.

Secondary

Measure	Time frame
Incidence and severity of adverse events (AEs)	24 months.
Maximum plasma concentration (Cmax)	24 months.
Time to reach Cmax (Tmax)	24 months.
Objective response rate (ORR)	24 months.

Countries

China

Contacts

CONTACTJunli Wang

junli.wang@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026