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

ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female.

Expected survival ≥ 3 months.

ECOG performance status 0 or 1.

Diagnosed with active multiple myeloma per IMWG criteria.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SHR-5421 for Injection

    Drug

    SHR-5421 for injection.

Treatment groups

97 Participants
are divided into 1 treatment group
Group A: SHR-5421 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 months.

Secondary outcomes

1

Incidence and severity of adverse events (AEs)

Time frame
24 months.
2

Maximum plasma concentration (Cmax)

Time frame
24 months.
3

Time to reach Cmax (Tmax)

Time frame
24 months.
4

Objective response rate (ORR)

Time frame
24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: