Multiple Myeloma study: IBI3003
Official title A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07336472
What this study is testing
What is IBI3003?
IBI3003 is an investigational medicine being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether IBI3003 can be safely given to people with relapsed or refractory multiple myeloma and whether it helps them.
- Who it's for
- You may be able to join if you have relapsed or refractory multiple myeloma and have tried other treatments.
- What's involved
- You will receive IBI3003 at a dose that is being tested. You will have regular visits and blood tests to check safety and how well it works.
- Time commitment
- The study lasts about 6 to 12 months, with several visits during the first few weeks and then monthly follow‑ups.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcemia: serum calcium...
- Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60% Involved: uninvolved serum free light chain...
- Relapsed or refractory measurable multiple myeloma (R/R MM) following prior treatment with ≥3 lines of systemic anti-myeloma therapy that include at...
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
You likely can't join if
- 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...
- 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...
- 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...
- Allogeneic hematopoietic stem cell transplantation within the last 6 months, or autologous stem cell transplantation within the last 3 months prior...
See the full eligibility criteria
Who can join
- Age ≥18 years.
- 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...
- 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...
- 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)...
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- 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 (\ 1.65)
- 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...
- 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
What rules you out
- 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...
- 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...
- 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)
- 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...
- 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 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).
- 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...
- 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...
- 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...
- Participating in any other treatment clinical research except an observational (noninterventional) study or the survival follow-up phase of an treatment 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
- Inability to comprehend or unwilling to sign the ICF
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Irvine, California, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Irvine, California, United States; New York, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.