RecruitingPhase 1Phase 2NCT06429150

Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

20 participants

Start Date

May 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • Male and female subjects with multiple myeloma or plasmacytoma
  • Strictly complete remission (sCR) is a treatment goal
  • Expected survival \> 12 weeks
  • After prior auto-SCT is eligible regardless of other prior therapies
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Voluntary informed consent is given and commitment to continued follow-up

Exclusion Criteria5

  • Pregnant or lactating women
  • Uncontrolled active infection
  • Active HIV, hepatitis B or hepatitis C infection
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  • Any medical conditions that may preclude participation

Interventions

BIOLOGICALCAR-T cells

Infusion of multi-CAR-T cells


Locations(2)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Hematologist of the Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health

Vladivostok, Russia

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NCT06429150


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