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NCT Number: NCT07090954

A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma

The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Fourth People's Hospital Affiliated with Tongji University, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group performance status grade of 0, 1 or 2;
  • Diagnosis of multiple myeloma；have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor.
  • Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.

Exclusion criteria

  • Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
  • Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  • Prior treatment with any BCMA-targeted therapiy.
  • Active infecion.
  • Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.

Treatment and study plan

GR1803 injection

Drug

Participants will receive GR1803 injection.

Anti-CD38 Monoclonal Antibody

Drug

Participants will receive anti-CD38 monoclonal antibody.

Primary outcomes

  1. Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT)

    Time frame: Up to 2 Years

    The dose limiting toxicities are defined as any of the following events: drug related hematological or non-hematological toxicity of grade 3 or higher.

  2. Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events

    Time frame: Up to 2 Years

    Adverse event is any untoward medical occurrence in a clinical trial participants administered a pharmaceutical product, regardless of causal relationship to the study treatment. This includes any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the product.

    Serious adverse event is an adverse event that results in any of the following outcomes: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important events.

  3. Dose expansion: Overall Response Rate

    Time frame: Up to 2 Years

    The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria

Secondary outcomes

  1. Duration of Response

    Time frame: Up to 2 Years

    Time from initial partial response or better to progressive disease or death due to any cause

  2. Progression-Free Survival

    Time frame: Up to 2 Years

    Time from first administration of GR1803 injection to tumor progerssion or death from any cause

  3. Serum Concentration of GR1803 Injection

    Time frame: Up to 2 Years

    Serum concentration of GR1803 injection will be assessed

  4. Number of Participants With Anti-Drug Antibodies to GR1803 Injection

    Time frame: Up to 2 Years

    Number of participants with anti-drug antibodies to GR1803 injection will be assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng P He, Doctor of Meicine

CONTACT

[email protected]

86+18991232609

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-Label, Multicenter, Phase Ib/II Clinical Trial of GR1803 Injection in Combination With an Anti-CD38 Monoclonal Antibody Evaluating Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Subjects With Relapsed/Refractory Multiple Myeloma Previously Treated With at Least One Line of Therapy Including Lenalidomide and a Proteasome Inhibitor

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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