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Multiple MyelomaPhase 1/2NCT07336472

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

A Phase 1/2 study testing IBI3003 in people with Multiple Myeloma, run by Fortvita Biologics (USA)Inc. at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
IBI3003
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
6 sitesUnited States
Study dates
30 Sep 2026to 30 Sep 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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:
  • Blood count: absolute neutrophil count ≥1.0×10^9/L, hemoglobin ≥70 g/L, and platelet count ≥50×10^9/L (values must be achieved without growth factors or blood transfusions within 7 days prior to first dose)
  • Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤2.5× upper limit of normal (ULN) and total bilirubin (TBIL) ≤1.5×ULN
  • Renal function: calculated creatinine ≥30 mL/min by the Cockcroft-Gault Equation
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%
  • Life expectancy ≥3 months.
  • Women of childbearing potential and fertile men who are sexually active must agree to use a highly effective method of contraception (<1% / year failure rate) during the study and for 90 days after the last dose level of study drug. Contraception must be consistent with local regulations or standards regarding the use of birth control methods by participants participating in clinical trials. Women and men must agree not to donate or bank eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days after the last dose level of study drug.
  • Participants 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.
  • Willing and able to adhere to the complete schedule of assessments and all prohibitions and restrictions specified in this protocol

Who cannot join

  • 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.
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  • 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.
  • Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer.
  • Antibody treatment (e.g., monoclonal antibody, bispecific antibody) for multiple myeloma within 21 days.
  • Cytotoxic therapy (including antibody-drug conjugates) within 14 days.
  • Proteasome inhibitor therapy within 14 days Immunomodulatory agent therapy within 7 days.
  • Radiotherapy within 21 days. However, if the radiation field covered ≤5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy.
  • Cancer vaccine received within 3 months.
  • Use of immunosuppressive therapy within 28 days of the start date of study treatment.
  • Immunosuppressive therapy includes, but is not limited to, cyclosporine A, tacrolimus, and mycophenolate mofetil, but does not include corticosteroids given as part of an antimyeloma regimen. Participants receiving corticosteroids must be at a dose level ≤10 mg/day of prednisone equivalent for at least 7 days prior to the start of study treatment administration.
  • Live or live attenuated vaccine administered within 4 weeks prior to start of study treatment, or anticipated need for live or live attenuated vaccine during the study.
  • Uncontrolled diseases, including:
  • Uncontrolled infection or infection requiring systemic antibiotics, antivirals or antifungals within one week prior to first administration of the study drug;
  • Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
  • For participants in mainland China, acute or chronic active hepatitis B (HBsAg positive and/or HBcAb positive with HBV DNA titer ≥104 copies/mL or ≥2000 IU/mL) or C (HCV Ab positive with HCV RNA>103 copies/mL). For participants outside of mainland China, active, latent or incompletely treated infection with HBV or HCV;
  • Failed to complete anti-tuberculosis therapy at any point prior to C1D1; active tuberculosis infection, or still on anti-tuberculosis therapy;
  • Active syphilis infection requiring treatment;
  • Symptomatic congestive heart failure Grade II-IV (New York Heart Association [NYHA]), symptomatic or uncontrolled arrhythmias, QTc interval (calculate using the Fridericia formula) >480 ms, or personal or family history of congenital long/short QT syndrome;
  • Uncontrollable hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg);
  • Active autoimmune diseases, including but not limited to inflammatory bowel disease, autoimmune hepatitis, demyelinating lesions, extensive dermatitis, immunerelated interstitial pneumonia, or Grave's disease requiring antithyroid medication control (vitiligo, or hypothyroidism requiring hormone replacement therapy, type I diabetes requiring only insulin replacement therapy and no other systemic therapy in the past 2 years are eligible); Presence of clinically uncontrolled pleural/peritoneal effusions (participants who do not require regular drainage or who do not demonstrate significant re-accumulation of effusion for at least 72 hours after the most recent drainage can enroll).
  • Major surgery within 2 weeks prior to the first dose of study treatment, not fully recovered from any prior surgery, or has non-minor surgery anticipated during the time the participant is expected to receive study drug or within 2 weeks after the last dose of study drug administration.
  • Participating in any other interventional clinical research except an observational (noninterventional) study or the survival follow-up phase of an interventional study.
  • Currently pregnant or breastfeeding.
  • Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Inability to comprehend or unwilling to sign the ICF

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fortvita Biologics CT.gov Call Center contact

650-370-0985

ct.govNotifications@fortvitabio.com

6 sites in 1 country

United States6 sites, 4 recruiting

  • Emory

    Atlanta, Georgia, 30322

    Active, not recruiting

  • City of Hope - Duarte

    Duarte, California, 91010

    Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com

    Recruiting

  • MD Anderson

    Houston, Texas, 77030

    Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com

    Recruiting

  • City of Hope - Lennar

    Irvine, California, 92618

    Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com

    Recruiting

  • Memorial Sloan Kettering

    New York, New York, 10021

    Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com

    Recruiting

  • Honor Health

    Scottsdale, Arizona, 85258

    Active, not recruiting

Other trials in United States

About this study

Official title: A Phase I/II, Multicenter, Open-label Study of IBI3003 in Participants With Relapsed or Refractory Multiple Myeloma

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

Being tested
IBI3003
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI3003Drug

    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.

Study groups in NCT07336472
Study groupRoleWhat they receive
IBI3003ExperimentalParticipants 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.
Receives: Drug: IBI3003

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

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

    Measured: Up to 30 days post last dose

  2. Dose limiting toxicities (DLTs)

    To evaluate the safety and tolerability of IBI3003

    Measured: Up to 28 days post first dose

  3. ORR

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

    Measured: up to 24 months

  4. 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

    Measured: up to 24 months

Secondary outcomes (19)

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

    To evaluate the immunogenicity of IBI3003

    Measured: up to 24 months

  2. Preliminary efficacy including objective response rate (ORR)

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

    Measured: up to 24 months

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

    To evaluate minimal residual disease (MRD) negativity rates.

    Measured: up to 24 months

  4. efficacy estimates sCRR

    stringent complete response rate. To evaluate other efficacy estimates of IBI3003 in the participant population.

    Measured: up to 24 months

  5. Incidence of TEAEs

    To evaluate the safety of IBI3003 in the participant population.

    Measured: up to 24 months

  6. half-life (T1/2)

    To characterize the pharmacokinetic (PK) profile of IBI3003.

    Measured: up to 24 months

  7. time to maximum concentration (Tmax)

    time to peak concentration. To characterize the pharmacokinetic (PK) profile of IBI3003.

    Measured: up to 24 months

  8. maximum concentration (Cmax)

    up to 24 months

    Measured: peak plasma concentration. To characterize the pharmacokinetic (PK) profile of IBI3003.

  9. area under the curve (AUC)

    area under the curve. To characterize the pharmacokinetic (PK) profile of IBI3003.

    Measured: up to 24 months

  10. complete response rate (CRR)

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

    Measured: up to 24 months

  11. very good partial response rate (VGPRR)

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

    Measured: up to 24 months

  12. duration of response (DoR)

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

    Measured: up to 24 months

  13. disease control rate (DCR)

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

    Measured: up to 24 months

  14. time to response (TTR)

    up to 24 months

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

  15. progression free survival (PFS).

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

    Measured: up to 24 months

  16. SAEs

    serious adverse events (SAEs) Adverse events will be assessed by investigator(s) To evaluate the safety of IBI3003 in the participant population.

    Measured: up to 24 months

  17. changes in laboratory parameters

    To evaluate the safety of IBI3003 in the participant population.

    Measured: up to 24 months

  18. physical examination findings

    A complete physical examination will include: general appearance, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and pharynx), lymph nodes, thyroid, musculoskeletal (including spine and extremities), genital/anal, and neurological assessments, if indicated. Clinically significant abnormal findings at screening will be recorded as medical history or AE based on the investigator's analysis and judgment.To evaluate the safety of IBI3003 in the participant population.

    Measured: up to 24 months

  19. vital signs

    Collection of vital signs will include temperature in ℃, measurement tool is physiological parameter.To evaluate the safety of IBI3003 in the participant population.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336472
Sponsor's protocol ID
CIBI3003A101EX
Status last verified
Sep 2026
First submitted
8 Jan 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IBI3003 in people with Multiple Myeloma, run by Fortvita Biologics (USA)Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fortvita Biologics CT.gov Call Center (650-370-0985, ct.govNotifications@fortvitabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: Up to 30 days post last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07336472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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Clinical Trial NCT07336472 | AzTrials