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A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Primary Purpose

Relapse Multiple Myeloma, Refractory Multiple Myeloma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
BCMA Targeted CAR T-cells
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse Multiple Myeloma focused on measuring multiple myeloma, CAR T-cell therapy, BCMA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Histologically confirmed diagnosis of multiple myeloma (MM):

    1. Patients with BCMA positive relapsed/refractory MM;
    2. Relapsed after hematopoietic stem cell transplantation;
    3. Cases with recurrent positive minimal residual disease;
    4. Repeated MRD(+) refractory resistant cases

    5. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

      2. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent.

      Exclusion Criteria:

  • Subjects with any of the following exclusion criteria were not eligible for this trial:

    1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
    2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
    3. Pregnant (or lactating) women;
    4. With a graft-versus-host response, immunosuppressants are required;
    5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
    6. Active infection of hepatitis B virus or hepatitis C virus;
    7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
    8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
    9. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
    10. Other uncontrolled diseases that were not suitable for this trial;
    11. Patients with HIV infection;
    12. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Sites / Locations

  • The First Affiliated Hospital, Medical College, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of BCMA Targeted CAR T-cells

Arm Description

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

Overall response rate (ORR)
Assessment of ORR at Day 28
Overall survival (OS)
Assessment of OS at Month 6, 12, 24
Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)
Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
Instrumental Activities of Daily Living (IADL) score
Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12
Activities of Daily Living (ADL) score
Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12
Hospital Anxiety and Depression Scale (HADS) score
Assessment of Hospital Anxiety and Depression Scale (HADS) score at Baseline, Month 1, 3, 6, 9 and 12

Full Information

First Posted
June 18, 2022
Last Updated
June 18, 2022
Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05430945
Brief Title
A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Official Title
Clinical Trial for the Safety and Efficacy of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Anticipated)
Primary Completion Date
June 20, 2025 (Anticipated)
Study Completion Date
June 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinical Trial for the safety and efficacy of BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Detailed Description
In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse Multiple Myeloma, Refractory Multiple Myeloma
Keywords
multiple myeloma, CAR T-cell therapy, BCMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of BCMA Targeted CAR T-cells
Arm Type
Experimental
Arm Description
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Intervention Type
Biological
Intervention Name(s)
BCMA Targeted CAR T-cells
Other Intervention Name(s)
BCMA Targeted CAR T-cells injection
Intervention Description
Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Description
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
Baseline up to 28 days after BCMA targeted CAR T-cells infusion
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time Frame
Up to 2 years after BCMA targeted CAR T-cells infusion
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Assessment of ORR at Day 28
Time Frame
At Day 28
Title
Overall survival (OS)
Description
Assessment of OS at Month 6, 12, 24
Time Frame
At Month 6, 12, 24
Title
Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)
Description
Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
Time Frame
At Baseline, Month 1, 3, 6, 9 and 12
Title
Instrumental Activities of Daily Living (IADL) score
Description
Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12
Time Frame
At Baseline, Month 1, 3, 6, 9 and 12
Title
Activities of Daily Living (ADL) score
Description
Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12
Time Frame
At Baseline, Month 1, 3, 6, 9 and 12
Title
Hospital Anxiety and Depression Scale (HADS) score
Description
Assessment of Hospital Anxiety and Depression Scale (HADS) score at Baseline, Month 1, 3, 6, 9 and 12
Time Frame
At Baseline, Month 1, 3, 6, 9 and 12

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed diagnosis of multiple myeloma (MM): Patients with BCMA positive relapsed/refractory MM; Relapsed after hematopoietic stem cell transplantation; Cases with recurrent positive minimal residual disease; Repeated MRD(+) refractory resistant cases Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy. 2. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for this trial: History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; With a graft-versus-host response, immunosuppressants are required; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxian Hu, PhD
Phone
86-15957162012
Email
huyongxian2000@aliyun.com
Facility Information:
Facility Name
The First Affiliated Hospital, Medical College, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Phone
86-13605714822
Email
hehuangyu@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

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