- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661554
BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma (BCMA CAR-T)
September 6, 2018 updated by: The Pregene (ShenZhen) Biotechnology Company, Ltd.
BCMA Nano Antibody CAR-T Cells for the Treatment of Refractory Relapsed Multiple ,Single Center, Single Arm and Open Clinical Study of Myeloma
This clinical study is an exploratory study, mainly to study the safety and efficacy of BCMA nano-antibody CAR-T in the treatment of MM.
In this study, a 3 + 3 dose gradient climbing design was used.
Three dosage groups, 5 x 106 / kg, 7.5 x 106 / kg and 1.5 x 107 / kg, were divided into three groups.
Patients were enrolled in the sequence from low to high doses.
When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity.
If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity.
Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed.
Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to study the safety and efficacy of BCMA nanoantibody CAR-T in the treatment of MM.
BCMA CAR is composed of BCMA nano-antibody, CD8 strand region, transmembrane region and 4-1BB costimulatory domain, and CD3-_T cell activation domain.
BCMA nano-antibody CAR-T cells were prepared by lentivirus infection of T cells.
In this study, a 3 + 3 dose gradient climbing design was used.
Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups.
Patients were enrolled in the sequence from low to high doses.
When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity.
If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity.
Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed.
Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled.
After transfusion, adverse events were closely monitored and therapeutic effects were evaluated on the 28th day after transfusion.
Follow-up was conducted every 6 weeks within 6 months and every 10 weeks after 6 months.
To evaluate the safety and efficacy of BCMA nano antibody CAR-T in the treatment of refractory and relapsed MM.
Study Type
Interventional
Enrollment (Anticipated)
15
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 Contact
- Name: jishuai zhang, doctor
- Phone Number: 13661255147
- Email: zhangjs@pregene.com
Study Locations
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Guangdong
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Shenzhen, Guangdong, China, 518000
- Recruiting
- Pregene Shenzhen Biotechnology Co., Ltd.
-
Contact:
- jishuai zhang
- Phone Number: 13661255147 13661255147
- Email: zhangjs@pregene.com
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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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-75 years, the expected survival time is greater than 3 months;
- Active MM was diagnosed, BCMA positive;
- At present, there is no effective treatment, such as chemotherapy or recurrence after hematopoietic stem cell transplantation, or patients voluntarily choose to infuse anti-BCMA nano-antibody CAR-T cells as the first treatment;
- ECOG : 0-2 points;
- Cardiac function: no heart disease or coronary heart disease, cardiac function 1-2;
- Liver function: TBIL < 3 ULN, AST < 2.5 ULN, ALT < 2.5 ULN;
- Renal function: Cr < 1.25 ULN;
- Patients with smooth peripheral venous access can meet the needs of intravenous drip;
- There are no other serious diseases (such as autoimmune diseases, immunodeficiency and organ transplantation) that are inconsistent with this protocol;
- There was no history of malignancy;
- Women of childbearing age must be tested for negative blood pregnancy tests within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial and within 3 months after the trial;
- Patients agreed to participate in the clinical study and signed the informed consent form.
Exclusion Criteria:
- Pregnant women or lactating women (women of childbearing age need to have a pregnancy check);
- Severe infectious diseases were found in the first 4 weeks of admission;
- Active hepatitis B or C viral hepatitis;
- HIV infected patients;
- Suffering from severe autoimmune or immunodeficiency diseases;
- Severe allergic constitution;
- Severe mental disorders;
- Systematic overuse of glucocorticoids within the first four weeks of admission (except for inhaled corticosteroids);
- Suffering from severe heart, liver, renal insufficiency, diabetes and other diseases;
- In the past 3 months, he participated in other clinical studies or previous treatment of other gene products.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: single arm
This clinical study, "BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma clinical research," is a single center, single arm, open design.
The aim is to study the safety and efficacy of BCMA nano antibody CAR-T in the treatment of MM.
In this study, a 3 + 3 dose gradient climbing design was used.
Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups.
|
The Chinese name of CAR-T cells is chimeric antigen receptor T cells.
It is through gene transfection technology, so that patients with T lymphocytes can carry B cell-specific antigens, so that T lymphocytes can selectively kill B lymphocyte-derived tumor cells.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 2 years
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Any adverse events associated with BCMA nanoscale CAR-T cell therapy during the trial period
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (ACTUAL)
April 10, 2018
Primary Completion (ANTICIPATED)
October 30, 2018
Study Completion (ANTICIPATED)
November 30, 2018
Study Registration Dates
First Submitted
September 3, 2018
First Submitted That Met QC Criteria
September 6, 2018
First Posted (ACTUAL)
September 7, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 10, 2018
Last Update Submitted That Met QC Criteria
September 6, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
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
- PRG 1801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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Shenzhen University General HospitalRecruitingMultiple Myeloma | Refractory Multiple Myeloma | Relapse Multiple MyelomaChina
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