Targeting CD19 and BCMA CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    24
  • sponsor
    Shanxi Province Cancer Hospital
Updated on 31 January 2021

Summary

Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-BCMA CAR-T cells for the treatment of multiple myeloma

Description

A non randomized study ,plans to enrollment 24 patients of B cell lymphoma divided into low, medium and high dose groupsto evaluate the safety and tolerability of CD19-BCMA CAR - T cells immunotherapy in patients with relapsed or refractory B cell lymphoma to evaluate the preliminary efficacy and observe PK/PD parameters of CD19-BCMA CAR - T cells immunotherapy in patients with relapsed or refractory multiple myeloma .

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment CD19-CD22 CAR-T cells
Clinical Study IdentifierNCT04714827
SponsorShanxi Province Cancer Hospital
Last Modified on31 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Agreed to participate in this study and signed informed consent, and willing to finish all the test procedure
Age 18 years of age, gender not limited
According to IMWG diagnosis of multiple myeloma patients
ECOG physical score 2 points
Relapsed multiple myeloma: disease progressed after received at least 3 lines treatment (must including the proteasome inhibitors and immune modulators); Refractory multiple myeloma: early treatment has never reached more than MR and curative effect; Or early treatment has reached more than MR and curative effect, but the subsequent treatment process or disease progress within 60 days after the last treatment
Have a measurable lesions in screening period (conform to one of the following standards: (1) the serum M protein: IgG protein10g/L, or IgA M protein 5g/L, or IgD M protein 5g/L; (2) M protein urine 200mg/24h; (3)If M protein in serum or urine cannot be measured,under the condition of the abnormal serum free light chain ratio,serum free light chain immunoglobulin or 100 mg/L
Test results in screening period: (1) Hb60 g/L (7 days before the inspection without blood transfusion),PLT 50 x 10 ^ 9 / L(7 days before the inspection without blood transfusion) ,ALC0.310^9/L,ANC0.7510^9/L; (2)AST3ULN,ALT3ULN,TBIL2ULNCcr30 mL/min/1.73 m2;Correction of serum calcium 3.1mmol/L12.5mg/dL; LVEF40% Baseline peripheral blood oxygen saturation 95%
Female subjects with fertility ,pregnancy blood test results should be negative in screening period and before remove the lymphocyte
Expected to survival more than 3 months

Exclusion Criteria

The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive subjects; Early syphilis screening antibody positive
The other clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection
Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure
In past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs
Had a history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis,etc which influence the appraising of test
Diagnosed with other active malignancy in past five years(the basal or scaly skin cancer, superficial bladder cancer, breast cancer in situ, which has been cured and does not require follow-up treatment are not included )
Known allergic to cyclophosphamide, fluorine dara marina or CAR - T cell s including accessories, DMSO
Patients with pregnancy or lactation, patients do not want to take effective contraceptive measures within 6months after infusion CAR-T cells
The other situations that researchers determined doesn't fit to participate in this study
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