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

NCT07336472 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CIBI3003A101EX
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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 54\~360 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Adverse events (AEs)

  Number of patients who Experienced related AEs from the first dose until 30 days after the last dose

  Up to 30 days post last dose

• Dose limiting toxicities (DLTs)

  To evaluate the safety and tolerability of IBI3003

  Up to 28 days post first dose

• ORR

  To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

  up to 24 months

• To determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3003

  To determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3003

  up to 24 months

Secondary Outcomes (19)

• Incidence and characterization of anti-drug antibody (ADA).

  up to 24 months

• Preliminary efficacy including objective response rate (ORR)

  up to 24 months

• To evaluate minimal residual disease (MRD) negativity rates. MRD negativity rate.

  up to 24 months

• efficacy estimates sCRR

  up to 24 months

• Incidence of TEAEs

  up to 24 months

Study Arms (1)

IBI3003

EXPERIMENTAL

Participants will receive IBI3003 treatment until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, or end of the study or for a maximum of 24 months, whichever occurs first.

Drug: IBI3003

Interventions

IBI3003 DRUG

Participants will receive IBI3003 treatment until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, or end of the study or for a maximum of 24 months, whichever occurs first.

IBI3003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in Parts 1 \& 2 must satisfy all of the following criteria to be enrolled in the study:
• Age ≥18 years.
• 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 myelomadefining events:
• Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or corrected serum calcium \>2.75 mmol/L (\>11 mg/dL) Renal insufficiency: creatinine clearance \<40 mL/min or serum creatinine \>177 μmol/L (\>2 mg/dL) Anemia: hemoglobin value of \>2 g/dL below the lower limit of normal, or a hemoglobin value \<10 g/dL Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT
• Any one or more of the following biomarkers of malignancy:
• Clonal bone marrow plasma cell percentage ≥60% Involved: uninvolved serum free light chain ratio ≥100 (involved FLC level must be
• ≥100 mg/L) \>1 focal lesions on MRI studies (at least 5 mm in size)
• Relapsed or refractory measurable multiple myeloma (R/R MM) following prior treatment with ≥3 lines of systemic anti-myeloma therapy that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy, and with limited or no therapeutic options that are likely to offer a favorable risk/benefit profile; participants must be relapsed or refractory to their last anti-myeloma regimen.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• At least one of the following measurable disease indicators:
• Serum M-protein ≥5 g/L (for IgA and IgD subtypes, quantitative immunoglobin measurements could be used as substitutions for M-protein)
• Urine M-protein ≥200 mg/24h
• Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio (\<0.26 or \>1.65)
• Adequate hematologic, hepatic, renal and cardiac function:

You may not qualify if:

• Participants who meet any of the following criteria will be disqualified from entering the study:
• Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• Active amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering multiple myeloma (MM) as defined by the IMWG criteria.
• Spinal cord compression that results in limited self-care at present or within 6 months prior to informed consent, or that is expected to cause such limitations during Study participation.
• History of primary immunodeficiency.
• 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.
• Allogeneic hematopoietic stem cell transplantation within the last 6 months, or autologous stem cell transplantation within the last 3 months prior to the first administration of the study drug.
• History of organ transplantation.
• Active graft-versus-host disease.
• Thromboembolism or cerebrovascular events (e.g., myocardial infarction, unstable angina, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \[unless associated with complications of central venous access\], or pulmonary embolism) within 6 months prior to the first dose of study drug.
• Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation.
• Known allergies, hypersensitivity, or intolerance to IBI3003 or its excipients (refer to Investigator's Brochure).
• Prior toxicities that have not resolved to ≤Grade 1 prior to study treatment administration except for stable chronic toxicities (≤Grade 2) not expected to resolve (e.g., stable Grade 2 peripheral neurotoxicity)
• Prior antitumor therapy as follows, prior to the first dose of study drug:
• Gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, natural killer cells) within 8 weeks.

Sponsors & Collaborators

• Fortvita Biologics (USA)Inc.: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Abe Castro

CONTACT

510-378-4296; abe.castro@fortvitabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-01