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

NCT ID: NCT03860038

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-28
• Study Completion Date: 2023-01-28

Brief 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.

Detailed Description

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).

Conditions

Multiple Myeloma in Relapse; Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TJ202

Group Type: EXPERIMENTAL

TJ202 and Dexamethasone

Intervention Type: DRUG

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.

Interventions

TJ202 and Dexamethasone

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TJ Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lugui Qiu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC

Locations

Beijing Chao-Yang Hospital,Capital medical university

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Nanfang Hospital of SMU

Guangzhou, Guandong, China

The second people's Hospital of Shenzhen

Shenzhen, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangzhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The first Bethune hospital of Jilin University

Changchun, Jilin, China

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

National Taiwan University Hospital

Taiwan, Taiwan, China

Tri-Service General Hospital

Taiwan, Taiwan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Sir Run Run Shaw Hospital，affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital, College of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

China; Taiwan

Other Identifiers

TJ202001MMY201

Identifier Type: -

Identifier Source: org_study_id