Actively Recruiting
Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma
Led by O&D BioTech Group CO., Limited · Updated on 2026-01-27
18
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, open and dose-escalation clinical study to evaluate the safety, tolerability, PK/PD characteristics and preliminary efficacy of the investigational drug O\&D-001 injection in the treatment of relapsed or refractory multiple myeloma.
CONDITIONS
Official Title
Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years, inclusive, regardless of gender.
- Voluntarily agree to participate, sign informed consent, and complete all trial procedures.
- Diagnosed with multiple myeloma according to internationally accepted criteria.
- Tumor sample tests positive for BCMA or GPRC5D expression on myeloma cells.
- Have received at least two prior anti-myeloma therapies including a proteasome inhibitor and an immunomodulatory agent, with documented disease progression.
- Have measurable disease based on specified blood, urine, or bone marrow tests before apheresis.
- ECOG Performance Status of 0-2.
- Life expectancy of at least 3 months.
- Normal major organ function meeting specific laboratory thresholds for blood counts, liver and kidney function, coagulation, oxygen saturation, and heart function.
- Use at least one medically recognized contraceptive method during the study if of childbearing potential, with negative pregnancy test for females of childbearing age and not lactating.
You will not qualify if you...
- Prior treatment with CAR-T/TCR-T/TIL or other cell therapies, or history of allogeneic organ or stem cell transplantation.
- Allergy or intolerance to study drugs or components of the cell therapy.
- Received systemic anti-tumor therapy within 2 weeks, monoclonal antibody therapy within 3 weeks, or radiotherapy within 2 weeks prior to apheresis (with some exceptions).
- Participated in another clinical trial within 4 weeks prior to apheresis or within 5 half-lives of an investigational drug.
- Use of prednisone >10 mg/day or equivalent corticosteroids within 1 week prior to apheresis.
- Major surgery within 2 weeks prior to apheresis.
- Presence of any uncontrolled active infection.
- Severe cardiac disease or severe arrhythmia.
- Unstable systemic diseases including uncontrolled hypertension, severe hepatic, renal, metabolic diseases, autoimmune diseases, immunodeficiency, or conditions requiring immunosuppressive therapy.
- Positive for hepatitis B or C with detectable virus, HIV antibody positive, or positive syphilis test.
- Other malignancies within 5 years except certain treated skin or in situ cancers.
- Autologous stem cell transplantation within 12 weeks prior to apheresis.
- Received live vaccines within 4 weeks prior to apheresis.
- History of central nervous system diseases or involvement by multiple myeloma.
- Diagnosis of plasma cell leukemia.
- Investigator deems subject unsuitable for any clinical or laboratory reason.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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