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

TJ Biopharma Co., Ltd.113 enrolled

Overview

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.

A total of 82 subjects with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of treatment will be enrolled in this study. Prior lines of treatment must include a proteasome inhibitor (PI) and an immunomodulator (IMiD). All subjects will receive TJ202 and dexamethasone (DEX) in the study. The treatment will continue until endpoint events such as intolerance or progressive disease (PD).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

113

Conditions

Multiple Myeloma in Relapse Refractory Multiple Myeloma

Interventions

TJ202 and DexamethasoneDRUG

one dose of TJ202 16 mg/kg or an adjusted dose will be administered on Day 1 and Day 4 of Week 1, then every week from Week 2 to Week 12, then every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter, until the subjects experience an onset of endpoint events like intolerance or PD. DEX 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Beijing Chao-Yang Hospital,Capital medical university

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Overall response rate (ORR)

defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)