- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04541368
A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy
December 9, 2020 updated by: He Huang, Zhejiang University
Clinical Trial for the Safety and Efficacy of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy
Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a single arm, open-label, single-center study.
This study is indicated for relapsed CS1+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products.
50 patients will be enrolled for this trial.
Primary objective is to explore the safety, main consideration is dose-related safety.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital,College of Medicine, Zhejiang University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Histologically confirmed diagnosis of CS1+ multiple myeloma (MM):
- Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression;
- Relapsed after hematopoietic stem cell transplantation;
- Cases with recurrent positive minimal residual disease;
- Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
- Anticipated survival time more than 12 weeks;
- Male or female aged 30-75 years;
- 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 hemorrhagicdiseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infectionand 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 inhaled 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 CS1 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 CS1 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 CS1 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 CS1 targeted CAR T-cells infusion
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Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after CS1 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 CS1 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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Quality of life
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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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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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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 31, 2020
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
August 19, 2020
First Submitted That Met QC Criteria
September 1, 2020
First Posted (Actual)
September 9, 2020
Study Record Updates
Last Update Posted (Actual)
December 10, 2020
Last Update Submitted That Met QC Criteria
December 9, 2020
Last Verified
December 1, 2020
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
- CS1-ZhejiangU
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
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.
Clinical Trials on Relapse Multiple Myeloma
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Memorial Sloan Kettering Cancer CenterRecruitingMultiple Myeloma | Refractory Multiple Myeloma | Relapse Multiple MyelomaUnited States
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Medical College of WisconsinWithdrawnRefractory Multiple Myeloma | Relapse Multiple Myeloma
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Dana-Farber Cancer InstituteBristol-Myers SquibbNot yet recruitingMultiple Myeloma | Multiple Myeloma in Relapse | Multiple Myeloma, RefractoryUnited States
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Andrew Yee, MDJanssen Research & Development, LLC; AmgenRecruitingMultiple Myeloma | Refractory Multiple Myeloma | Relapse | Multiple Myeloma in RelapseUnited States
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OncotherapeuticsNot yet recruitingMultiple Myeloma in Relapse | Multiple Myeloma, Refractory
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National Cancer Institute (NCI)CompletedStage II Multiple Myeloma | Stage III Multiple Myeloma | Multiple Myeloma in RelapseUnited States
Clinical Trials on CS1 Targeted CAR T-cells
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Zhejiang UniversityYake Biotechnology Ltd.RecruitingRefractory Multiple Myeloma | Relapse Multiple MyelomaChina
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Southwest Hospital, ChinaUnknownLymphoma, Large B-Cell, DiffuseChina
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Zhejiang UniversityYake Biotechnology Ltd.Not yet recruitingRefractory Multiple Myeloma | Relapse Multiple MyelomaChina
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Zhejiang UniversityShanghai YaKe Biotechnology Ltd.Recruiting
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He HuangYake Biotechnology Ltd.RecruitingRelapse/Refractory Multiple MyelomaChina
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Zhejiang UniversityShanghai YaKe Biotechnology Ltd.Not yet recruitingNon-hodgkin Lymphoma,B Cell | Acute Lymphoblastic Leukemia,B-CellChina
-
He HuangYake Biotechnology Ltd.RecruitingRelapsed and Refractory | Lymphoid Hematological MalignanciesChina
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Southwest Hospital, ChinaUnknown
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Southwest Hospital, ChinaUnknownLymphoma | Leukemia | Multiple MyelomaChina
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Southwest Hospital, ChinaUnknown