Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma

NCT07369895 | Recruiting Phase 1

• 1 other identifier: O&D-001-IIT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  28 days after the first O&D-001 infusion.

• Adverse Events (AE) and Serious Adverse Events (SAE)

  up to 6 months

Study Arms (1)

IV Dose-Escalation Cohort

EXPERIMENTAL

Single dose administration of O\&D-001 via intravenous infusion.

Biological: Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D

Interventions

Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D BIOLOGICAL

Using the traditional 3+3 dose escalation method.

IV Dose-Escalation Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• O&D BioTech Group CO., Limited: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: October 28, 2025
• Primary Completion (Estimated): March 28, 2028
• Study Completion (Estimated): March 28, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)