- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05430945
A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Clinical Trial for the Safety and Efficacy of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital, Medical College, Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Administration of BCMA Targeted CAR T-cells
Dose escalation follows the standard 3+3 dose escalation design.
A total of 3 dose levels are set for subjects.
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Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity (DLT)
Time Frame: Baseline up to 28 days after BCMA targeted CAR T-cells infusion
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Adverse events assessed according to NCI-CTCAE v5.0 criteria
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Baseline up to 28 days after BCMA targeted CAR T-cells infusion
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Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after BCMA targeted CAR T-cells infusion
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Incidence of treatment-emergent adverse events [Safety and Tolerability]
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Up to 2 years after BCMA targeted CAR T-cells infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activities of Daily Living (ADL) score
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
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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
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At Baseline, Month 1, 3, 6, 9 and 12
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Instrumental Activities of Daily Living (IADL) score
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
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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
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At Baseline, Month 1, 3, 6, 9 and 12
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Overall response rate (ORR)
Time Frame: At Day 28
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Assessment of ORR at Day 28
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At Day 28
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Overall survival (OS)
Time Frame: At Month 6, 12, 24
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Assessment of OS at Month 6, 12, 24
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At Month 6, 12, 24
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Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
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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
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At Baseline, Month 1, 3, 6, 9 and 12
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Hospital Anxiety and Depression Scale (HADS) score
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
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Assessment of Hospital Anxiety and Depression Scale (HADS) score at Baseline, Month 1, 3, 6, 9 and 12
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At Baseline, Month 1, 3, 6, 9 and 12
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- BCMA-ZhejiangU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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