Status:

RECRUITING

a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Lead Sponsor:

Chongqing Precision Biotech Co., Ltd

Conditions:

Multiple Myeloma

Neoplasm, Plasma Cell

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

PHASE2

Brief Summary

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

Detailed Description

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will e...

Eligibility Criteria

Inclusion Criteria:

  1. Signed written informed consent;

  2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:

    1. Failed to standard chemotherapy regimens;
    2. Relapse after complete remission, high-risk and / or refractory patients ;
    3. Relapse after hematopoietic stem cell transplantation;
  3. Evidence for cell membrane BCMA expression

  4. All genders, ages: 18 to 75 years#

  5. The expect time of survive is above 3 months;

  6. KPS>60

  7. No serious mental disorders ;

  8. Left ventricular ejection fraction ≥50%

  9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;

  10. Sufficient renal function defined by creatinine clearance≤2 x ULN;

  11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;

13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

  1. Previous history of other malignancy;
  2. Presence of uncontrolled active infection;
  3. Evidence of disorder that need the treatment by glucocorticoids;
  4. Active or chronic GVHD
  5. The patients treatment by inhibitor of T cell
  6. Pregnant or breasting-feeding women;
  7. 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.

Key Trial Info

Start Date :

March 7 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2027

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04776330

Start Date

March 7 2021

End Date

July 1 2027

Last Update

February 25 2025

Active Locations (1)

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1

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China