Actively Recruiting
A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Chimeric Antigen Receptor T Cell (O&D-001) Injection Targeting BCMA and GPRC5D 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of the investigational chimeric antigen receptor T cell drug O&D-001 injection for treating adults with relapsed or refractory multiple myeloma. This phase 1, single-center, open-label, dose-escalation study focuses on patients who have failed at least two prior anti-myeloma therapies and whose tumors express the BCMA or GPRC5D proteins. Participants will receive a single intravenous infusion of O&D-001 using a traditional 3+3 dose escalation method to identify safe dosing levels. The study includes monitoring for dose-limiting toxicities within 28 days after infusion and adverse events for up to 6 months. The treatment targets specific proteins on myeloma cells to assess preliminary efficacy and biological effects. During the study, participants will undergo multiple evaluations including tumor specimen testing, blood tests, bone marrow biopsies, and assessments of organ function and performance status. Researchers will closely monitor side effects, measure tumor markers, and assess overall health and life expectancy. The study lasts several months, with follow-up to evaluate safety and tolerability after treatment.
CONDITIONS
Brief 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.
- Meet internationally accepted diagnostic criteria for multiple myeloma.
- Tumor specimen tests positive for BCMA or GPRC5D expression on myeloma cells.
- Have received at least 2 prior lines of anti-myeloma therapy including at least one proteasome inhibitor and one immunomodulatory agent.
- Have documented progressive disease during or within 12 months after last therapy.
- Have measurable disease as defined by specific serum, urine, or bone marrow criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy of at least 3 months.
- Normal major organ function as defined by specific lab values and clinical criteria.
- Use at least one medically recognized contraceptive method if of childbearing potential during the study period.
- Female subjects of childbearing age must have negative pregnancy test and not be lactating before therapy.
You will not qualify if you...
- Prior treatment with CAR-T, TCR-T, TIL, or other cell therapies.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Allergy or intolerance to study drugs or components.
- Recent systemic anti-tumor therapy, monoclonal antibody therapy, or radiotherapy within specified timeframes before apheresis, with exceptions.
- Participation in another clinical trial within 4 weeks prior to apheresis.
- 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 uncontrolled active infection.
- Severe cardiac disease or unstable systemic diseases.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with certain conditions.
- Other malignancies within 5 years except certain skin or carcinoma in situ treated curatively.
- Autologous stem cell transplantation within 12 weeks prior to apheresis.
- Live vaccines within 4 weeks prior to apheresis.
- History of CNS diseases or CNS involvement by multiple myeloma.
- Diagnosis of plasma cell leukemia.
- Investigator's judgment of unsuitability due to clinical or laboratory abnormalities or other reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after the first infusion
Participants receive a single dose administration of the O&D-001 injection via intravenous infusion targeting BCMA and GPRC5D.
1 baseline visit and weekly visits for monitoring during the first 28 days
Duration - Up to 6 months
Participants are monitored for adverse events and serious adverse events for up to 6 months after treatment.
Periodic visits for safety monitoring
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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