Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma

NCT03380039 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-10-12

No results posted yet for this study

Summary

A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.

Conditions

  • Refractory or Relapsed Multiple Myeloma

Interventions

GENETIC

CAR-BCMA T cells

Single dose of CAR-BCMA T cells will be infused, and classic "3+3" dose escalation will be applied.

DRUG

Fludarabine

Fludarabine is used for lymphodepletion.

DRUG

Cyclophosphamide

Cyclophosphamide is used for lymphodepletion.

Sponsors & Collaborators

  • CARsgen Therapeutics Co., Ltd.

    collaborator INDUSTRY
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Siguo Hao, MD · Xin Hua Hospital of Shanghai Jiao Tong University of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2020-07-02
Completion
2023-07-02

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380039 on ClinicalTrials.gov