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BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

NCT03664661 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-09-10

No results posted yet for this study

Summary

Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma

Conditions

  • Relapsed/Refractory Myeloma

Interventions

DRUG

BCMA nanobody CAR-T cells

step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients. After finishing this, another 6 patients will be enrolled for observation of efficacy.

Sponsors & Collaborators

  • The Pregene (ShenZhen) Biotechnology Company, Ltd.

    collaborator INDUSTRY

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Yongping Song, M.D · Henan Cancer Hospital

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2019-04-10
Completion
2020-04-30

Countries

  • China

Study Locations

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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 NCT03664661 on ClinicalTrials.gov