A Phase I Study of SHR-3836 in Patients With Multiple Myeloma

An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 in Patients With Multiple Myeloma

This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: SHR-3836 administered as multiple doses.

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Depei Wu; Phone Number: +0512-67976372; Email: drwudepei@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Principal Investigator: Depei Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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-3836.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-3836 for injection	Drug: SHR-3836 administered as multiple doses.; In the dose escalation phase, doses are escalated sequentially from low to high levels.; In the dose expansion phase, one or more selected dose levels are further evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determination of Phase II Dose (RP2D) of SHR-3836	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	24 months
Incidence and severity of adverse events (AE) of SHR-3836	24 months
Maximum plasma concentration (Cmax)	24 months
Time to reach Cmax (Tmax)	24 months

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: SHR-3836-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No