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Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

NCT03711864 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-09-30

No results posted yet for this study

Summary

In patients with multiple myeloma with recurrent or refractory BCMA, CAR-T cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10\^5 / kg, 1 x 10\^6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group).

Conditions

Interventions

BIOLOGICAL

IM21 CAR-T cells

fludarabine and cyclophosphamide Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days

Sponsors & Collaborators

  • Beijing Immunochina Medical Science & Technology Co., Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Daobin Zhou, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2021-10-10
Completion
2021-12-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03711864 on ClinicalTrials.gov