TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion criteria:


  1. Age ≥ 18, male or female;
  2. Subject must have had documented MM;
  3. At screening phase, subject must have measurable disease;
  4. Subject is in a state of progressive disease (PD);
  5. Subject must have life expectancy of no less than 6 months;
  6. Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;

EXCLUSION CRITERIA

Exclusion criteria:


  1. Subject has received anti-CD38 monoclonal antibody treatment previously;
  2. Subject has received CAR-T cell therapy previously;
  3. 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;
  4. Primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy);
  5. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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
Phase 2
Participants needed
113
Est. Completion Date
Dec 31, 2023
Treatment type
Interventional

Sponsor
I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov identifier
NCT03860038
Study number
TJ202001MMY201

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