RecruitingPhase 1Phase 2NCT06083207

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

116 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 23\~116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new immunotherapy drug called IBI3003 in patients with multiple myeloma (a blood cancer affecting plasma cells in the bone marrow) whose cancer has returned or stopped responding to prior treatments. The drug is designed to help the immune system recognize and attack myeloma cells. **You may be eligible if...** - You are 18 or older (up to 75 for the initial dose-escalation phase) - You have been diagnosed with multiple myeloma according to standard criteria - Your cancer has returned or is not responding to treatment - You have good overall health (ECOG 0 or 1) - Your expected survival is at least 3 months - You can give written informed consent **You may NOT be eligible if...** - Your myeloma has spread to the brain or nervous system - You have related conditions like AL amyloidosis, plasma cell leukemia, or POEMS syndrome - You have had spinal cord compression in the last 6 months - You have had another cancer within the past 3 years (except certain skin or in-situ cancers) - You have a primary immune deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIBI3003

Subjects will receive IBI3003 on Day 1 in a 28-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and pharmacokinetic(PK) data), until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.


Locations(13)

Wollongong Private Hospital

Wollongong, New South Wales, Australia

Austin Hospital

Heidelberg, Victoria, Australia

St Vincent's Hospital

Melbourne, Victoria, Australia

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The first Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Tongji Medical College of HUST Tongji Hospital

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of XI'AN Jiaotong University

Xian, Shanxi, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06083207


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