Integrin β7, BCMA, CS1, CD38 and CD138 as the Single or Compound Targets for the Fourth Genenation of CAR-T Cells
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|ClinicalTrials.gov Identifier: NCT03778346|
Recruitment Status : Unknown
Verified November 2020 by The Sixth Affiliated Hospital of Wenzhou Medical University.
Recruitment status was: Recruiting
First Posted : December 19, 2018
Last Update Posted : November 18, 2020
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|Condition or disease||Intervention/treatment||Phase|
|RRMM||Biological: CAR-T therapy in Relapsed/Refractory multiple myeloma||Phase 1|
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways including proteasome inhibitors and immune regulator and hematopoietic stem cell transplantation . Combined with the advantages of multiple therapies, chimeric antigen receptor T cells (CAR-T) have gradually becoming one of the strongest and most powerful weapons against multiple myeloma.The basic principle is to use the patient's own immune cells to clear cancer cells.
MM is genetically and phenotypically heterogeneous,Antigen escape and relapse after CAR-T treatment is a global problem， so the effective treatment of refractory/relapsing multiple myeloma with CAR-T cells usually requires targeting multiple antigens. The investigators use Integrin β7(a large family of molecules that are central regulators in multicellular biology and orchestrating cell-cell and cell-extracellular matrix (ECM) adhesive interactions from embryonic development to mature tissue function), BCMA(highly expressed on malignant MM plasma cells and providing a substantial antiapoptotic signal making it an encouraging target for BCMA-directed immunotherapy),CS1(encoded by the SLAMF7 gene,a robust marker of normal plasma cells and malignant plasma),CD38(encoded by the CD38 gene and functioning in cell adhesion, signal transduction and calcium signaling) and CD138(known as syndecan 1, a surface protein expressed on most healthy and malignant plasma cells as an adhesion protein, binding collagen and fibronectin molecules located in the extracellular matrix. ) as the Single or Compound Targets for the Fourth Genenation of CAR-T Cells ,thereby effectively treating refractory/recurrent multiple myeloma .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrin β7, BCMA, CS1, CD38 and CD138 as the Single or Compound Targets for the Fourth Genenation of CAR-T Cells|
|Actual Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: CAR-T therapy in multiple myeloma
In order to assess the safety and validity of using the Fourth Genenation of CAR-T therapy refractory/rela-psed multiple myeloma patients with one kind of BCMA-CART,CD138-CART,CD38-CART , Integrin β7-CART or 10 different combinations ,subjects will receive 10^6-10^7/Kg transduced CAR-T cells at one time.
Biological: CAR-T therapy in Relapsed/Refractory multiple myeloma
Integrin β7, BCMA, CS1, CD38 and CD138 as the Single or Compound Targets for the Fourth Genenation of CAR-T Cells to treat Relapsed/Refractory multiple myeloma
- Adverse events that are related to treatment [ Time Frame: 2 years ]Safety and tolerability measured by occurrence of study related adverse effects defined by NCI-CTCAE v4.03
- 2 year overall survival(OS) [ Time Frame: 2 yaers ]To estimate 2 year overall survival(OS) after BCMA/CD138/CD38/Integrinβ7/CS1-CART infusion and sequential treatment with Relapsed/Refractory MM
- 3 year progression free survival (PFS) [ Time Frame: 3 yaers ]To estimate 3 year progression free survival after BCMA/CD138/CD38/Integrinβ7/CS1 CART infusion and sequential treatment with Relapsed/Refractory MM
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients who meet the requirements voluntarily participate in the study and sign the Informed Consent Form.
- Age is 18 to 80 years old, gender is not limited.
- Patients with relapsed or refractory myeloma who meet the following criteria for multiple myeloma diagnostic criteria defined by the IMWG (2017): Subjects have received adequate prior treatment of at least 2 regimens; during the most recent treatment or after treatment , the disease progresses or recurs.
- The Eastern Cancer Cooperative Group (ECOG) scores 0 to 2 (the tumor causes bone pain).
- The expected survival period is more than 12 weeks.
- No other malignant tumors, severe autoimmune diseases or congenital immunodeficiency, serious progressive infection, cranial nerve disorder or mental illness.
- Pregnant or lactating women.
- Patients with uncontrollable active infections.
- Patients with systemic steroids; recent or current use of inhaled steroids is not excluded.
- Previously involved CAR-T cell therapies produced any uncontrolled disease.
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): NCT03778346
|Contact: Bingmu Fang, M.Dfirstname.lastname@example.org|
|Contact: Yonghua Liu, M.Demail@example.com|
|Lishui, Zhejiang, China, 323000|
|Contact: Jiang Jinhong, M.D 0578-2780108 firstname.lastname@example.org|
|Contact: Jiang Jinhong, M.D|
|Sub-Investigator: Jiang Jinhong|
|The Sixth Affiliated Hospital of Wenzhou Medical University||Recruiting|
|Lishui, Zhejiang, China, 323000|
|Contact: Bingmu Fang, M.D 0578-2780108 email@example.com|
|Principal Investigator: Bingmu Fang, M.D|
|Zhejiang QiXin Biotech||Recruiting|
|Wenzhou, Zhejiang, China, 325035|
|Contact: Jimin Gao, M.D., Ph.D. 86-577-86699341 firstname.lastname@example.org|
|Contact: Ai Zhao, M.D., Ph.D. 86-577-86699341 email@example.com|
|Principal Investigator: Jimin Gao, M.D., Ph.D.|
|Sub-Investigator: Ai Zhao, M.D., Ph.D.|
|Principal Investigator:||Bingmu Fang, M.D||Lishui Country People's Hospital|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||The Sixth Affiliated Hospital of Wenzhou Medical University|
|Other Study ID Numbers:||
|First Posted:||December 19, 2018 Key Record Dates|
|Last Update Posted:||November 18, 2020|
|Last Verified:||November 2020|
|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|