Clincosm LogoSign in Get a demo

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

Sponsor
I-Mab Biopharma Co. Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03860038
Collaborator
(none)
113
Enrollment
18
Locations
1
Arm
47.1
Anticipated Duration (Months)
6.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TJ202 and Dexamethasone
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
113 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 28, 2019
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Overall response rate (ORR) [end of study [ Time Frame: Approximately up to 2 years ]]

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

Secondary Outcome Measures

  1. Clinical benefit rate (CBR) [end of study [ Time Frame: Approximately up to 2 years ]]

  2. Duration of response (DOR) [end of study [ Time Frame: Approximately up to 2 years ]]

  3. Time to progression (TTP) [end of study [ Time Frame: Approximately up to 2 years ]]

  4. Time to response (TTR) [end of study [ Time Frame: Approximately up to 2 years ]]

  5. Progression-free survival (PFS) [end of study [ Time Frame: Approximately up to 2 years ]]

  6. Overall survival (OS) [end of study [ Time Frame: Approximately up to 2 years ]]

Other Outcome Measures

  1. minimal residual disease (MRD) assessment [end of study [ Time Frame: Approximately up to 2 years ]]

    For subjects reaching CR and above, their bone marrow samples will be collected for exploratory minimal residual disease (MRD) assessment at the central laboratory.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chao-Yang Hospital,Capital medical university Beijing Beijing China
2 Peking Union Medical College Hospital Beijing Beijing China
3 Fujian Medical University Union Hospital Fuzhou Fujian China
4 Nanfang Hospital of SMU Guangzhou Guandong China
5 The second people's Hospital of Shenzhen Shenzhen Guangdong China
6 Sun Yat-sen University Cancer Center Guangzhou Guangzhou China
7 Henan Cancer Hospital Zhengzhou Henan China
8 Jiangsu Province Hospital Nanjing Jiangsu China
9 The first Bethune hospital of Jilin University Changchun Jilin China
10 Shanghai Changzheng Hospital Shanghai Shanghai China
11 National Taiwan University Hospital Taiwan Taiwan China
12 Tri-Service General Hospital Taiwan Taiwan China
13 Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin Tianjin China
14 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China
15 Tianjin Medical University General Hospital Tianjin Tianjin China
16 Sir Run Run Shaw Hospital，affiliated with the Zhejiang University School of Medicine Hangzhou Zhejiang China
17 The First Affiliated Hospital, College of Medicine,Zhejiang University Hangzhou Zhejiang China
18 Taipei Veterans General Hospital Taipei Taiwan 11217

Sponsors and Collaborators

  • I-Mab Biopharma Co. Ltd.

Investigators

  • Principal Investigator: Lugui Qiu, Doctor, Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov Identifier:
NCT03860038
Other Study ID Numbers:
  • TJ202001MMY201
First Posted:
Mar 1, 2019
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone

Study Results

No Results Posted as of Jul 8, 2022