BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

September 7, 2018 updated by: Henan Cancer Hospital

a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yongping Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 and ≤70 years old and the expected lifetime >3 months

    • Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
    • No effective treatment option available
    • ECOG score 0-2
    • Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
    • smoothly peripheral superficial veins
    • No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
    • No history of other malignancies
    • Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
    • The patient himself agrees to participate in this clinical study and signed the "informed consent"

Exclusion Criteria:

  • Severe infectious 4 weeks before enrollment
  • Active hepatitis B or C viral hepatitis, HIV,
  • Severe autoimmune disease or immunodeficiency disease
  • Severe allergies
  • Severe mental disorder
  • Patients who used high-dose glucocorticoids within 1 week
  • Participation in other clinical studies in the past 3 months or having been treated with other gene products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental group
BCMA nanobody CAR-T cells
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of study related adverse events
Time Frame: 4 weeks
safety of CAR-T cells
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response rate
Time Frame: 3 months and 6 months
response rate according to IMWG criteria
3 months and 6 months
copy number of CAR-T cells
Time Frame: one year
copy number of CAR-T cells
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Collaborators

The Pregene (ShenZhen) Biotechnology Company, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2018

Primary Completion (ANTICIPATED)

April 10, 2019

Study Completion (ANTICIPATED)

April 30, 2020

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (ACTUAL)

September 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH CAR 2-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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