BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma (BCMA CAR-T)
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ClinicalTrials.gov Identifier: NCT03661554 |
Recruitment Status : Unknown
Verified September 2018 by The Pregene (ShenZhen) Biotechnology Company, Ltd..
Recruitment status was: Recruiting
First Posted : September 7, 2018
Last Update Posted : September 10, 2018
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Condition or disease | Intervention/treatment | Phase |
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Relapsed and Refractory Multiple Myeloma | Biological: BCMA CAR-T Cells | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 1 x 107 / kg and 1.5 x 107 / kg, were divided into three groups. |
Masking: | None (Open Label) |
Masking Description: | Clinical study of BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma (single center, single arm, open clinical study) |
Primary Purpose: | Treatment |
Official Title: | BCMA Nano Antibody CAR-T Cells for the Treatment of Refractory Relapsed Multiple ,Single Center, Single Arm and Open Clinical Study of Myeloma |
Actual Study Start Date : | April 10, 2018 |
Estimated Primary Completion Date : | October 30, 2018 |
Estimated Study Completion Date : | November 30, 2018 |
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.
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Biological: BCMA CAR-T Cells
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. |
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]Any adverse events associated with BCMA nanoscale CAR-T cell therapy during the trial period
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661554
Contact: jishuai zhang, doctor | 13661255147 | zhangjs@pregene.com |
China, Guangdong | |
Pregene Shenzhen Biotechnology Co., Ltd. | Recruiting |
Shenzhen, Guangdong, China, 518000 | |
Contact: jishuai zhang 13661255147 ext 13661255147 zhangjs@pregene.com |
Responsible Party: | The Pregene (ShenZhen) Biotechnology Company, Ltd. |
ClinicalTrials.gov Identifier: | NCT03661554 |
Other Study ID Numbers: |
PRG 1801 |
First Posted: | September 7, 2018 Key Record Dates |
Last Update Posted: | September 10, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |