- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04003168
Human BCMA Targeted T Cells Injection Therapy for BCMA-positive Relapsed/Refractory Multiple Myeloma
A Phase I Clinical Trial to Evaluate the Safety and Efficacy of Human BCMA Targeted T Cells Injection for Subjects With BCMA-positive Relapsed/Refractory Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Hongliang Fang, doctor
- Phone Number: 021-58552006
- Email: fanghongliang@dashengbio.com
Study Locations
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Henan
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Zhengzhou, Henan, China
- Recruiting
- The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
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Shanghai
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Shanghai, Shanghai, China, 200003
- Recruiting
- Shanghai Changzheng Hospital
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Contact:
- Weijun Fu, Professor
- Phone Number: 021-81885423
- Email: fuweijun2010@hotmail.com
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Recruiting
- The First Affiliated Hospital of Wenzhou Medical University
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Contact:
- Kang Yu, Professor
- Phone Number: 0577-55579486
- Email: yukang62@126.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects volunteer to participate in clinical research, understand and know the research and sign informed consent document, willing to complete all the trial procedures;
- 18 to 70 Years Old, Male and female;
- Expected survival > 12 weeks;
- Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
- Patients with positive pathological test results or flow cytometry proving that BCMA expression of malignant plasma cells in bone marrow or plasma cell tumors ≥30%;
One of the following indicators is satisfied:
- Serum M protein IgG ≥ 10 g/L, or IgA > 10 mg/L, or IgD > 5 mg/L;
- Urine M protein ≥ 200 mg/24h;
- Serum free light chain ≥ 100 mg/L;
Patients with relapsed/refractory multiple myeloma. Relapsed is defined as:
Patients have disease progression after at least three-line treatment regimens. Patients previously received at least 3 different mechanisms treatment regimens for multiple myeloma, including protease inhibitors and immunomodulators, and have disease progression within 60 days of the latest treatment ; Refractory is defined as: Patients who achieved remission in the piror therapies, have disease progression within 60 days, or after the latest therapy.
- Those who relapse 90 days after stem cell transplantation
- ECOG score 0-1;
Liver, kidney and cardiopulmonary functions meet the following requirements:
- Creatinine clearance (estimated by Cockcroft Gault formula) ≥ 40 mL/min;
- Left ventricular ejection fraction >50%;
- Baseline peripheral oxygen saturation >95%;
- Total bilirubin ≤ 2×ULN; ALT and AST ≤2.5 × ULN;
- The venous access required for collection can be established, and no leukocyte collection contraindications.
Exclusion Criteria:
- Accompanied by other uncontrolled malignancies;
- Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis primary screening antibody positive;
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), severe arrhythmia, liver, kidney or metabolic disease with poor drug control;
- Patients who are accounted to be not appropriate for this trail by investigator;
- Pregnant or lactating, or planning to have a pregnancy during or within 1 year after treatment;
- Received CAR-T treatment or other gene therapies before enrollment;
- Those who failed to sign informed consent form or comply with the research procedures; Unwilling or unable to comply with research requirements;
- Have had severe immediate hypersensitivity reactions to any drugs used in this research;
- The presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
- In the past two years, the terminal organ was damaged due to autoimmune diseases (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;
- Have a history of central nervous system (CNS) disease, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, psychosis.
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: Human BCMA targeted T Cells Injection
A single infusion of anti-BCMA CAR transduced T cells administered intravenously at a target dose of 3 to 9 x 10^6 CAR T +cells/kg.
The classic "3+3" dose escalation will be applied.
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Autologous genetically modified anti-BCMA CAR transduced T cells
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0
Time Frame: 28 days post infusion
|
28 days post infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of remission (DOR) after administration
Time Frame: 2 years post infusion
|
2 years post infusion
|
Progress Free Survival (PFS) after administration
Time Frame: 2 years post infusion
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2 years post infusion
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Overall Survival (OS)after administration
Time Frame: 2 years post infusion
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2 years post infusion
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Concentration of Anti-BCMA CAR T Cells in blood
Time Frame: 2 years post infusion
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2 years post infusion
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Concentration of Anti-BCMA CAR T Cells in bone marrow
Time Frame: 2 years post infusion
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2 years post infusion
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Pharmacodynamics (Levels of Cytokines in Serum)
Time Frame: 2 years post infusion
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2 years post infusion
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Pharmacodynamics (Content of clonal plasma cells in bone marrow)
Time Frame: 2 years post infusion
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2 years post infusion
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Overall response rate (ORR) after administration
Time Frame: 3 months post infusion
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3 months post infusion
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Negative proportion of minimal residual disease (MRD)
Time Frame: 28 days post infusion
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28 days post infusion
|
Positive incidence of anti-drug antibody
Time Frame: 2 years post infusion
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2 years post infusion
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Collaborators and Investigators
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
- HRAIN01-MM01
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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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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