RecruitingPhase 1NCT04162353

BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma


Sponsor

iCell Gene Therapeutics

Enrollment

12 participants

Start Date

Jul 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.


Eligibility

Inclusion Criteria5

  • Signed written informed consent; Patients volunteer to participate in the research
  • Diagnosis is mainly based on the World Health Organization (WHO) 2008
  • Patients have exhausted standard therapeutic options
  • Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
  • Female must be not pregnant during the study

Exclusion Criteria4

  • Patients declining to consent for treatment
  • Prior solid organ transplantation
  • Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  • Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents

Interventions

BIOLOGICALBCMA-CD19 cCAR T cells

BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy


Locations(2)

Peking University Shenzhen Hospital, China

Shenzhen, Guangdong, China

Chengdu Military General Hospital

Chengdu, Sichuan, China

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NCT04162353


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