Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorO&D BioTech Group CO., Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Sequential
Treatments tested in this trial
Chimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D
Biological/VaccineUsing the traditional 3+3 dose escalation method.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: IV Dose-Escalation CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity (DLT)
Time frame
28 days after the first O&D-001 infusion.2
Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame
up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov