TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
About the study
This trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion criteria:
- Age ≥ 18, male or female;
- Subject must have had documented MM;
- At screening phase, subject must have measurable disease;
- Subject is in a state of progressive disease (PD);
- Subject must have life expectancy of no less than 6 months;
- Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;
EXCLUSION CRITERIA
Exclusion criteria:
- Subject has received anti-CD38 monoclonal antibody treatment previously;
- Subject has received CAR-T cell therapy previously;
- Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent;
- Primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy);
- Subject has received anti-myeloma treatment (radiotherapy is excluded) within 4 weeks or 5 PK half-lives of the treatment, whichever longer, before the first study agent administration.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Multiple Myeloma in Relapse,Refractory Multiple Myeloma
Age (in years)
18+
Phase
PHASE2
Participants needed
113
Est. Completion Date
Dec 31, 2024
Treatment type
INTERVENTIONAL
Sponsor
TJ Biopharma Co., Ltd.
ClinicalTrials.gov identifier
NCT03860038
Study number
TJ202001MMY201
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