- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322292
A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Gang An, PhD&MD
- Phone Number: 008613502181109
- Email: angang@ihcams.ac.cn
Study Locations
-
-
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TianJin, China, 300000
- Recruiting
- InstituteHBDH
-
Contact:
- Gang An, PhD&MD
- Phone Number: +008613502181109
- Email: angang@ihcams.ac.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-75 years old, male or female;
- The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
- Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014);
- Patients with a clear diagnosis of relapsed or refractory multiple myeloma who have received at least 3 lines of MM (Contains proteasome inhibitors and immunomodulatory therapies that progress or relapse during the most recent treatment or after the end of treatment). Note: The planned treatment plan for one or more cycles is "one-line treatment"; induction chemotherapy, stem cell transplantation, and maintenance treatment (if there is no disease progression between them), it is considered as a one-line treatment plan;
The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- Serum M protein≥1.0 g/dL(10g/L)
- Urine M protein≥200 mg/24h
- Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
- Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
- ECOG scores 0 - 1;
- Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no severe arrhythmia;
- No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
- Absolute neutrophil count ≥1.0 × 109 / L, platelet count ≥50 × 109 / L; total serum bilirubin ≤1.5mg / dl; serum ALT or AST less than 2.5 times the upper limit of normal; serum creatinine ≤2.0mg / dl;
- No contraindications of peripheral blood apheresis;
- Expected survival time > 12 weeks;.
- Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.
Exclusion Criteria:
- Have a history of allergy to cell ular products;
- Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
- A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
- Need to use any anticoagulant (except aspirin);
- Patients requiring urgent treatment due to tumor progression or spinal cord compression;
- Patients with CNS metastasis or symptoms of CNS involvement;
- After allogeneic hematopoietic stem cell transplantation;
- Plasma cell leukemia;
- Received systemic anti-tumor treatment within 2 weeks before apheresis, and within 1 week before apheresis, prednisone (or equivalent amount of other corticosteroids) was applied in excess of 5 mg/d ;
- Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
- Uncontrolled active infection;
- Have used any CAR T cell products or other genetically modified T cell therapy before;
- Live vaccination within 4 weeks before enrollment;
- Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons;
- Have a history of alcoholism, drug addiction and mental illness;
- Participated in any other clinical trial within 1 months;
- The investigators believe that there are other circumstances that are not suitable for the trial.
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: C-CAR088
Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene.
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Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg. Divided into three dose ranges of low(1.0-3.0×10^6 CAR+T cells/kg),medium(3.0-6.0×10^6 CAR+T cells/kg) and high(6.0-9.0×10^6 CAR+T cells/kg). Other Name: CBM.BCMA Chimeric Antigen Receptor T cell. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: The incidence of treatment-emergent adverse events (TEAEs)
Time Frame: 30 days
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The incidence of treatment-emergent adverse events (TEAEs)
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The CART cell duration in vivo
Time Frame: 12 months
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The copys of BCMA-CART DNA in peripheral blood with qPCR method
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12 months
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The soluble BCMA changes in peripheral blood
Time Frame: 12 months
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The amount of soluble BCMA in peripheral blood with ELISA method
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12 months
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Overall response rate (ORR)
Time Frame: 12 months
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ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)
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12 months
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Progression free survival (PFS)
Time Frame: 6 months、12 months
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PFS(based on IMWG 2016 efficacy evaluation criteria)
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6 months、12 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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
- QT-2019007-EC-2
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.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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IlDong Pharmaceutical Co LtdCompleted
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International Centre for Diarrhoeal Disease Research...University of California, DavisCompletedMalnourished Children
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University of MiamiRecruitingHypoplastic Left Heart SyndromeUnited States
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Eli Lilly and CompanyCompleted
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Eli Lilly and CompanyCompletedAdvanced CancerUnited Kingdom
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Direction Centrale du Service de Santé des ArméesRecruitingEating Habit | Cold Exposure | HeatFrance