Status:
UNKNOWN
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Safety and Efficacy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
CART therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with high risk multiple myeloma after auto-HSCT...
Detailed Description
Adults ages 18-75 with high risk Multiple Myelomas (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment). ...
Eligibility Criteria
Inclusion
- Multiple myeloma patients eligible for auto-HSCT.
- High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment).
- Expected survival ≥ 3 months.
- Creatinine \< 2.0 mg/dl.
- Blood coagulation function: PT and APTT \<2x normal.
- Arterial blood oxygen saturation\>92%.
- ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal
- Karnofsky scores ≥ 60 and ECOG score≤2.
- Adequate venous access for apheresis, and no other contraindications for leukapheresis.
- Patients should not take immunotherapy in three months prior to CART cells infusion.
- Voluntary informed consent is given.
Exclusion
- Pregnant or lactating women.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- History of myocardial infarction and severe arrhythmia in half a year.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Patients with fever of unknown origin (T\>38℃).
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03455972
Start Date
February 20 2018
End Date
December 1 2023
Last Update
May 19 2021
Active Locations (1)
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1
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000