The aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT).
* Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens.
* MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor.
* Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
* Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
* Residual disease after primary therapy and not eligible for ASCT
* Expected survival \> 12 weeks
* Creatinine \< 2.5 mg/dl
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Any relapse after prior SCT is eligible regardless of other prior therapy
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given
Exclusion Criteria:
* 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.
* Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation
* HIV infection
Primary outcome measure(s)
Percentage of patients with treatment related adverse effect — 1 month percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.
Trial sites (1)
Facility
City
Region
Status
Shenzhen Geno-immune Medical Institute
Shenzhen
Guangdong
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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