NCT07652281

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
34mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Apr 2029

Study Start

First participant enrolled

June 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Determination of Phase II Dose (RP2D) of SHR-5421

    24 months.

Secondary Outcomes (4)

  • 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.

Study Arms (1)

SHR-5421 Group

EXPERIMENTAL

SHR-5421 administered as multiple doses.

Drug: SHR-5421 for Injection

Interventions

SHR-5421 for InjectionDRUG

SHR-5421 for injection.

SHR-5421 Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years, male or female.
  • Expected survival ≥ 3 months.
  • ECOG performance status 0 or 1.
  • Diagnosed with active multiple myeloma per IMWG criteria.
  • Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.
  • Disease progression or non-response to the most recent therapy.
  • Measurable disease as defined by serum/urine M-protein or serum free light chain.
  • Adequate bone marrow, hepatic, renal, and coagulation function.
  • Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception.
  • Willing and able to provide written informed consent and comply with study procedures.

You may not qualify if:

  • Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
  • Central nervous system involvement by tumor.
  • History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
  • Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
  • Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
  • Concurrent participation in another clinical study.
  • Prior anti-tumor therapy within specified washout periods.
  • Major surgery within 28 days prior to informed consent or planned during the study.
  • Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
  • Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.
  • Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).
  • Active infection.
  • Known hypersensitivity or contraindication to SHR-5421.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Junli Wang

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This is a phase I, open-label, dose escalation and expansion study of SHR-5421 in patients with relapsed or refractory multiple myeloma.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 17, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations

CN(1)