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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: I-Mab Biopharma Co. Ltd.; I-Mab Biopharma HongKong Limited
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

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:

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.