Testing IBI3003 for patients 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

This study is testing a new treatment called IBI3003 to see if it can help people with relapsed or refractory multiple myeloma feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 13 sites (Wollongong, New South Wales and 12 other locations)
• Trial ID: NCT06083207 on ClinicalTrials.gov

What this trial studies

This is a phase 1/2 multicenter, open-label study evaluating IBI3003 in patients with relapsed or refractory multiple myeloma. The study consists of a dose escalation phase to determine the maximum tolerated dose and a subsequent phase to assess the efficacy, safety, and tolerability of IBI3003 at the recommended dose. It aims to enroll between 23 to 116 subjects who meet specific eligibility criteria related to their condition and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a documented diagnosis of relapsed or refractory multiple myeloma.

Not a fit: Patients with active CNS involvement or other specific hematological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar investigational therapies in multiple myeloma, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Subjects in Parts 1(dose escalation) \& 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:

  1. Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
  2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. Multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events in protocol
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  4. Life expectancy ≥3 months.
  5. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

Exclusion Criteria:

1. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
2. Have amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering MM as defined by the International Myeloma Working Group(IMWG) criteria.
3. Spinal cord compression that results in limited self-care occurs within 6 months prior to informed consent, or is expected to occur in the near future.
4. History of primary immunodeficiency.
5. Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.

Where this trial is running

Wollongong, New South Wales and 12 other locations

• Wollongong Private Hospital — Wollongong, New South Wales, Australia (Suspended)
• Austin Hospital — Heidelberg, Victoria, Australia (Suspended)
• St Vincent's Hospital — Melbourne, Victoria, Australia (Suspended)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The first Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• Tongji Medical College of HUST Tongji Hospital — Wuhan, Hubei, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• ZhongShan Hospital FuDan University — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital of XI'AN Jiaotong University — Xian, Shanxi, China (Not_yet_recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Serena Dong

Conditions Multiple Myeloma