A Phase I Clinical Trial of Y150 in the Treatment of Relapsed or Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05011097|
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : August 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Multiple Myeloma||Drug: Y150||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety, Tolerability, PK/PD and Immunogenicity Characteristics of Recombinant Anti-CD38 and Anti-CD3 Bispecific Antibodies (Y150) for Injection in Patients With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||July 8, 2021|
|Estimated Primary Completion Date :||July 30, 2023|
|Estimated Study Completion Date :||December 30, 2024|
Subjects who meet the enrollment criteria will enter the core treatment period and receive a cycle of treatment with Y150 (once weekly for 4 weeks) via intravenous infusion. And eligible subjects who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance.
Subjects will receive an intravenous infusion of Y150 in a dose escalation once a week for a 28-day treatment cycle until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
- Number of Participants With Adverse Events according to CTCAE V5.0 [ Time Frame: up to approximately 2 years ]An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From the time of first dosing (Day 1) until the forth dosing (Day 28) ]DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0.
- Area under the curve (AUC) of Y150 [ Time Frame: Up to 1 weeks after the fourth dosing. ]
- Peak Plasma Concentration (Cmax) of Y150 [ Time Frame: Up to 1 weeks after the fourth dosing. ]
- Half-time (t1/2) of Y150 [ Time Frame: Up to 1 weeks after the fourth dosing. ]
- lymphocyte subsets in peripheral blood [ Time Frame: 12 months (anticipated) ]including CD3/CD4/CD8/CD14/CD19/CD38/CD45/CD56/CD69 lymphocyte subsets in peripheral blood
- Cytokines levels in serum [ Time Frame: 12 months (anticipated) ]including IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-α, IFN-γ levels in serum
- Anti-drug antibodies(ADAs) titer [ Time Frame: 12 months (anticipated) ]
- neutralizing antibody titer [ Time Frame: 12 months (anticipated) ]
- Objective Response Rate (ORR) [ Time Frame: 12 months (anticipated) ]ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR), based on International Myeloma Working Group (IMWG) criteria.
- Time to Progression (TTP) [ Time Frame: 12 months (anticipated) ]TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression.
- Duration of Response [ Time Frame: 12 months (anticipated) ]Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.
- Progression-Free Survival (PFS) [ Time Frame: 12 months (anticipated) ]PFS was defined as the time between the date of first dose of Y150 and either disease progression or death, whichever occurs first.
- Overall Survival (OS) [ Time Frame: 12 months (anticipated) ]OS was defined as the number of days from administration of the first infusion (Day 1) to date of death.
- Time to first Response [ Time Frame: 12 months (anticipated) ]Time to first response was defined as the time from the date of first dose of Y150 to the date of initial documentation of a response (PR or better).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05011097
|Contact: Mengwan Peiemail@example.com|
|Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College||Recruiting|
|Tianjin, Tianjin, China|
|Contact: Lugui Qiu, MD firstname.lastname@example.org|
|Principal Investigator: Lugui Qiu, MD|
|Principal Investigator: Junyuan Qi, MD|
|The First Affiliated Hospital Zhejiang University School of Medicine||Not yet recruiting|
|Hangzhou, Zhejiang, China|
|Contact: Zhen Cai, MD|
|Principal Investigator: Zhen Cai, MD|