RecruitingPhase 1Phase 2NCT04271644

BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

80 participants

Start Date

Apr 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria16

  • Signed written informed consent;
  • Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:
  • Failed to standard chemotherapy regimens;
  • Relapse after complete remission, high-risk and / or refractory patients ;
  • Relapse after hematopoietic stem cell transplantation;
  • Evidence for cell membrane BCMA expression;
  • All genders, ages: 18 to 75 years;
  • The expect time of survive is above 3 months;
  • KPS\>60;
  • No serious mental disorders ;
  • Left ventricular ejection fraction ≥50%
  • Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  • Sufficient renal function defined by creatinine clearance≤2 x ULN;
  • Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
  • With single or venous blood collection standards, and no other cell collection contraindications;
  • Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria7

  • Previous history of other malignancy;
  • Presence of uncontrolled active infection;
  • Evidence of disorder that need the treatment by glucocorticoids;
  • Active or chronic GVHD;
  • The patients treatment by inhibitor of T cell;
  • Pregnant or breasting-feeding women;
  • Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Interventions

BIOLOGICALBCMA CAR-T cells

BCMA CAR-T cell therapy


Locations(1)

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

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NCT04271644


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