NCT06083207 A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
| NCT ID | NCT06083207 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2024-07-29 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 116 participants in total. It began in 2024-07-29 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06083207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06083207 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06083207 currently recruiting?
Yes, NCT06083207 is actively recruiting participants. Contact the research team at suhua.dong@innoventbio.com for enrollment information.
Where is the NCT06083207 trial being conducted?
This trial is being conducted at Wollongong, Australia, Heidelberg, Australia, Melbourne, Australia, Beijing, China and 9 additional locations.
Who is sponsoring the NCT06083207 clinical trial?
NCT06083207 is sponsored by Innovent Biologics (Suzhou) Co. Ltd.. The trial plans to enroll 116 participants.