Status:
UNKNOWN
Integrin β7, BCMA, CS1, CD38 and CD138 as the Single or Compound Targets for the Fourth Genenation of CAR-T Cells
Lead Sponsor:
The Sixth Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Zhejiang Qixin Biotech
Conditions:
RRMM
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
According to the high expression of tumor cell-associated antigen CD138, integrin β7, CS1, CD38 and BCMA in patients with refractory/recurrent multiple myeloma, the fourth generation of CAR-T cells(si...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03778346
Start Date
November 15 2018
End Date
December 31 2022
Last Update
November 18 2020
Active Locations (3)
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1
Jinhong Jiang
Lishui, Zhejiang, China, 323000
2
The Sixth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, China, 323000
3
Zhejiang QiXin Biotech
Wenzhou, Zhejiang, China, 325035