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

A Phase 2, Multi-center, Single-arm Study of TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 2 Prior Lines of Treatment

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.

Study Overview

• Status: Completed
• Conditions: Refractory Multiple Myeloma; Multiple Myeloma in Relapse
• Intervention / Treatment: Drug: TJ202 and Dexamethasone

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).

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Beijing Chao-Yang Hospital,Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Union Hospital
  • Guandong
    • Guangzhou, Guandong, China
      • Nanfang Hospital of SMU
  • Guangdong
    • Shenzhen, Guangdong, China
      • The Second People's Hospital of Shenzhen
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • Sun Yat-sen University Cancer Center
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Bethune Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Changzheng Hospital
  • Taiwan
    • Taiwan, Taiwan, China
      • National Taiwan University Hospital
    • Taiwan, Taiwan, China
      • Tri-Service General Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin, China
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
  • Zhejiang
    • Hangzhou, Zhejiang, 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
• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TJ202

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	end of study [ Time Frame: Approximately up to 2 years ]

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical benefit rate (CBR)	end of study [ Time Frame: Approximately up to 2 years ]
Duration of response (DOR)	end of study [ Time Frame: Approximately up to 2 years ]
Time to progression (TTP)	end of study [ Time Frame: Approximately up to 2 years ]
Time to response (TTR)	end of study [ Time Frame: Approximately up to 2 years ]
Progression-free survival (PFS)	end of study [ Time Frame: Approximately up to 2 years ]
Overall survival (OS)	end of study [ Time Frame: Approximately up to 2 years ]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
minimal residual disease (MRD) assessment	For subjects reaching CR and above, their bone marrow samples will be collected for exploratory minimal residual disease (MRD) assessment at the central laboratory.	end of study [ Time Frame: Approximately up to 2 years ]

Collaborators and Investigators

• Sponsor: TJ Biopharma Co., Ltd.
• Investigators: Principal Investigator: Lugui Qiu, Doctor, Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): January 28, 2023
• Study Completion (Actual): January 28, 2023

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: TJ202001MMY201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No