Anti-BCMA CAR-NK Cell Therapy for the Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    27
  • sponsor
    Xinqiao Hospital of Chongqing
Updated on 28 November 2021

Summary

The purpose of this study is to infuse BCMA CAR-NK cellsUmbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Details
Condition Multiple Myeloma, Refractory
Treatment Fludarabine, Cytoxan, Anti-BCMA CAR-NK Cells
Clinical Study IdentifierNCT05008536
SponsorXinqiao Hospital of Chongqing
Last Modified on28 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed written informed consent
According to the international standard for multiple myelomahave information on medical examination proving the diagnosis of multiple myeloma
Received at least 2 prior lines of treatment, including proteasome inhibitor and immunomodulator, no efficacy more than PD; disease progression or relapsed after disease remission and refractory or no remission after treated in the last time
Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level veing as defined or light chain MM without measurable disease in the serum or the urineserum immunoglobulin free light chain isease dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio
ECOG Scores: 0~2See Annex 3the estimated survival time was more than 3 months
During the screening period, the clinical laboratory values met the following criteria Hemoglobins70g/L (did not receive red blood cell transfusion 7 days prior to laboratory testsrecombinant human erythropoietin is allowed); Platelet count >5010^9/L (did not receive blood transfusion 7 days prior to laboratory tests); Neutrophil absolute count oietin is (did not receive supportive treatment lowed); Platelet count >5010^9/Lallowed to use over growth factor support); ALT and AST 3ULNTotal bilirubin 2.0 UNLCreatinine clearance40mL/mincorrected serum calcium L/minctordL (3.1 mmol/L), or free calcium ion or freedL(L( ommol/L); Prothrombin time and activated partial thromboplastin time 1.5ULN
The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation
Females of childbearing potential and males must use efficient contraceptionform signing the ICF to the end of the trial

Exclusion Criteria

Have received CAR-NK therapy
Have a history of allergy to any component of cell products
Previous history of other malignancy
Any unstable cardiovascular disease happened the informed consent form by themselves or their legal guardian;boratory tests); be infused using the "3 + 3" dos grade), severe arrhythmia that require drug interference, cardiac angioplasty/coronary stent implantation/cardiac bypass surgery 6 months prior to enrollment
Have received allogeneic hematopoietic stem cell transplantation in 3 months for the treatment of multiple myeloma
who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease
There were live vaccinations within 4 weeks before admission
Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection
Oxygen is needed to maintain adequate oxygen saturation
Contraindications for fludarabine or cyclophosphamide treatment
There was uncontrolled active infection;Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive excluding glucocorticoidtherapy
Pregnant or breasting-feeding women
Subjects had a history of alcohol, drug or mental illness
Any other condition that researcher think it is inappropriate for the subject to anticipate the trial
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