NCT03322735

Brief Summary

The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 8, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 29, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

October 19, 2017

Last Update Submit

December 28, 2017

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    number of participants with adverse events

    1 year

Secondary Outcomes (2)

  • Persistence of the BCMA CAR+ T cells

    1 year

  • anti-tumor responses of BCMA CAR-T cells

    1 year

Study Arms (1)

anti-tumor response of BCMA CAR-T

EXPERIMENTAL

Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days. Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.

Drug: FludarabineDrug: CyclophosphamideBiological: BCMA CAR-T

Interventions

FludarabineDRUG

25-30mg/m2/day IV for 3 days

anti-tumor response of BCMA CAR-T
CyclophosphamideDRUG

cyclophosphamide 0.6-0.8g/m2/day IV for 2 days

anti-tumor response of BCMA CAR-T
BCMA CAR-TBIOLOGICAL

BCMA CAR-T cells will be administered after completion of the chemotherapy.

anti-tumor response of BCMA CAR-T

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 18 years to 70 years, expected survival \> 3 months;
  • \. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
  • \. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.；
  • \. ECOG performance status of 0-2;
  • \. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN;
  • \. No serious allergic constitution;
  • \. No other serous diseases that conflicts with the clinical program;
  • \. No other cancer history;
  • \. female participants of reproductive potential must have a negative serum pregnancy test;
  • \. Subjects must have signed written, informed consent.

You may not qualify if:

  • \. Pregnant or lactating women;
  • \. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
  • \. Active hepatitis B or hepatitis C infection;
  • \. Recent or current use of glucocorticoid or other immunosuppressor;
  • \. serious mental disorder;
  • \. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
  • \. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Yongping Song

    Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongping Song

CONTACT

+86-13521186987ph200811@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 26, 2017

Study Start

December 8, 2017

Primary Completion

October 1, 2018

Study Completion

December 1, 2019

Last Updated

December 29, 2017

Record last verified: 2017-10

Locations

CN(1)