Relapsed or Refractory Multiple MyelomaPhase 1NCT07369895
Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D in people with Relapsed or Refractory Multiple Myeloma, run by O&D BioTech Group CO., Limited at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to 28 Mar 2028
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, inclusive, regardless of gender.
- Subjects voluntarily agree to participate in this study, sign the informed consent form, and are willing to complete all trial procedures.
- Meets the internationally accepted diagnostic criteria for multiple myeloma (IMWG Diagnostic Criteria 2016, Appendix 1).
- Tumor specimen (bone marrow) from the subject tests positive for BCMA or GPRC5D expression on the myeloma cell membrane via immunohistochemistry (IHC) or flow cytometry.
- Patients with multiple myeloma who have received at least 2 prior lines of anti-myeloma therapy, including failure of at least one proteasome inhibitor and one immunomodulatory agent; each line of therapy should have consisted of at least one complete treatment cycle, unless the best response to that therapy was documented as Progressive Disease (PD) (according to the 2016 IMWG Response Criteria, Appendix 1); must have documented PD during or within 12 months after the last line of therapy.
- Has measurable disease, defined as meeting at least one of the following criteria prior to apheresis: serum M-protein ≥5 g/L; urine M-protein ≥200 mg/24 hours; for subjects with light chain multiple myeloma not meeting the above serum or urine M-protein criteria, an abnormal serum free light chain (sFLC) ratio with involved FLC ≥100 mg/L; >5% clonal plasma cells in bone marrow aspirate or biopsy as assessed by cytology or flow cytometry.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy of at least 3 months.
- Major organ function is normal, defined as meeting the following criteria:
- Hemoglobin ≥8.0 g/dL (No red blood cell (RBC) transfusion within 7 days prior to laboratory testing; use of recombinant human erythropoietin is allowed. For subjects who meet the inclusion criteria at screening, RBC transfusion is permitted after the first hematology test at screening to maintain hemoglobin level ≥8.0 g/dL.)
- Platelets ≥50×10⁹/L (No platelet transfusion or transfusion support within 7 days prior to laboratory testing)
- Absolute Neutrophil Count (ANC) ≥1.0×10⁹/L (Previous use of growth factor support is allowed, but no supportive treatment within 7 days prior to laboratory testing).
- AST and ALT ≤3.0 × Upper Limit of Normal (ULN).
- Creatinine Clearance ≥40 mL/min (Cockcroft-Gault formula).
- Total Bilirubin ≤1.5 × ULN.
- Corrected Serum Calcium ≤12.5 mg/dL (≤3.1 mmol/L) or Ionized Calcium ≤6.5 mg/dL (≤1.6 mmol/L).
- Fibrinogen ≥1.0 g/L.
- Activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN.
- Prothrombin Time (PT) ≤1.5 × ULN.
- Oxygen Saturation (on room air, without oxygen supplementation) ≥92%.
- Left Ventricular Ejection Fraction (LVEF) ≥50%.
- Subjects with childbearing potential must use at least one medically recognized contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period (from screening to 24 months after cell infusion). Female subjects of childbearing age must have a negative serum/urine HCG test within 7 days prior to cell therapy initiation and must not be lactating.
Who cannot join
- Prior treatment with CAR-T/TCR-T/TIL or other cell therapies; known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Allergy or intolerance to any of the study drugs (including chemotherapy preconditioning drugs and tocilizumab) or to any component of the cell therapy product.
- Received systemic anti-tumor therapy within 2 weeks prior to apheresis; or monoclonal antibody therapy for multiple myeloma within 3 weeks prior to apheresis; or radiotherapy within 2 weeks prior to apheresis, unless the radiation field involved ≤5% of the bone marrow reserve, in which case the subject is eligible regardless of the end date of radiotherapy.
- Participated in another clinical trial within 4 weeks prior to apheresis or within 5 half-lives of the investigational drug (whichever is longer).
- Use of prednisone >10 mg/day (or equivalent dose of other corticosteroids) within 1 week prior to apheresis.
- Underwent major surgery within 2 weeks prior to apheresis.
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- Presence of any uncontrolled active infection.
- Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] class ≥Ⅲ), or severe arrhythmia.
- Unstable systemic diseases as judged by the investigator, including but not limited to: uncontrolled hypertension despite medication; severe hepatic, renal, or metabolic diseases requiring pharmacological treatment; autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive therapy.
- Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have a hepatitis B virus (HBV) DNA titer above the lower limit of the normal range of the study center; subjects who are positive for hepatitis C virus (HCV) antibody and have detectable peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; subjects with positive syphilis testing.
- Diagnosis of malignancies other than multiple myeloma within 5 years prior to screening (except for carcinoma in situ [e.g., breast, bladder, cervical carcinoma in situ] or basal cell carcinoma or squamous cell carcinoma of the skin that have received potentially curative treatment).
- Received autologous stem cell transplantation within 12 weeks prior to apheresis.
- Received live vaccines within 4 weeks prior to apheresis.
- History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis; known active or history of CNS involvement or clinical signs indicating meningeal/spinal meningeal involvement by multiple myeloma.
- Diagnosis of plasma cell leukemia.
- The investigator deems the subject unsuitable for participation in this clinical study due to any clinical or laboratory abnormality or other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Yang Liang, +86-020-87340823, liangyang@sysucc.org.cn
About this study
Official title: 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
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
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5DBiological
Using the traditional 3+3 dose escalation method.
| Study group | Role | What they receive |
|---|---|---|
| IV Dose-Escalation Cohort | Experimental | Single dose administration of O\&D-001 via intravenous infusion. Receives: Biological: Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Measured: 28 days after the first O&D-001 infusion.
Adverse Events (AE) and Serious Adverse Events (SAE)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start28 Oct 2025
- Primary completion28 Mar 2028 (estimated)
- Study completion28 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This study presets three dosage groups.Using the traditional 3+3 dose escalation method, 3 - 6 subjects with relapsed or refractory multiple myeloma are planned to be enrolled in each dose group. Dose escalation studies will be conducted sequentially from the low - dose group to the high - dose group.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- O&D BioTech Group CO., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369895
- Sponsor's protocol ID
- O&D-001-IIT
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07369895
- Acronym / sponsor ID
- O&D-001-IIT
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- O&D BioTech Group CO., LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 28 Mar 2028 (estimated)
- Study completion
- 28 Mar 2028 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study presets three dosage groups.Using the traditional 3+3 dose escalation method, 3 - 6 subjects with relapsed or refractory multiple myeloma are planned to be enrolled in each dose group. Dose escalation studies will be conducted sequentially from the low - dose group to the high - dose group.
| Arm | Type | Receives |
|---|---|---|
| IV Dose-Escalation Cohort | Experimental | Biological: Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5DSingle dose administration of O\&D-001 via intravenous infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Aged 18-75 years, inclusive, regardless of gender.
- Subjects voluntarily agree to participate in this study, sign the informed consent form, and are willing to complete all trial procedures.
- Meets the internationally accepted diagnostic criteria for multiple myeloma (IMWG Diagnostic Criteria 2016, Appendix 1).
- Tumor specimen (bone marrow) from the subject tests positive for BCMA or GPRC5D expression on the myeloma cell membrane via immunohistochemistry (IHC) or flow cytometry.
- Patients with multiple myeloma who have received at least 2 prior lines of anti-myeloma therapy, including failure of at least one proteasome inhibitor and one immunomodulatory agent; each line of therapy should have consisted of at least one complete treatment cycle, unless the best response to that therapy was documented as Progressive Disease (PD) (according to the 2016 IMWG Response Criteria, Appendix 1); must have documented PD during or within 12 months after the last line of therapy.
Key exclusion criteria (16 listed)
- Prior treatment with CAR-T/TCR-T/TIL or other cell therapies; known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Allergy or intolerance to any of the study drugs (including chemotherapy preconditioning drugs and tocilizumab) or to any component of the cell therapy product.
- Received systemic anti-tumor therapy within 2 weeks prior to apheresis; or monoclonal antibody therapy for multiple myeloma within 3 weeks prior to apheresis; or radiotherapy within 2 weeks prior to apheresis, unless the radiation field involved ≤5% of the bone marrow reserve, in which case the subject is eligible regardless of the end date of radiotherapy.
- Participated in another clinical trial within 4 weeks prior to apheresis or within 5 half-lives of the investigational drug (whichever is longer).
- Use of prednisone >10 mg/day (or equivalent dose of other corticosteroids) within 1 week prior to apheresis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5DUsing the traditional 3+3 dose escalation method. | Biological | IV Dose-Escalation Cohort |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: 28 days after the first O&D-001 infusion.
Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D in people with Relapsed or Refractory Multiple Myeloma, run by O&D BioTech Group CO., Limited at 1 site in China.
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 22 inclusion and 16 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: 28 days after the first O&D-001 infusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.