NCT04162119

Brief Summary

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with relapsed/refractory Multiple Myeloma.

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
30

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Jul 2019

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

Study Start

First participant enrolled

July 7, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

November 11, 2019

Last Update Submit

November 14, 2019

Conditions

Multiple Myeloma

Keywords

BCMAMyelomaPD-1ImmunotherapyPlasmocytomaChimeric antigen receptor T cellChimeric antigen receptorB cell maturation antigen

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-related Adverse Events

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).

    3 years

Secondary Outcomes (5)

  • Overall Remission Rate(ORR) of BCMA-PD1-CART cells in Lymphoma

    3 years

  • Overall survival(OS) of BCMA-PD1-CART cells in Lymphoma

    3 years

  • Progress-free survival(PFS) of BCMA-PD1-CART cells in Lymphoma

    3 years

  • Rate of BCMA-PD1-CARTcells in peripheral blood cells

    3 years

  • Quantity of BCMA-PD1-CART cells copies in peripheral blood cells.

    3 years

Study Arms (1)

multiple myeloma

EXPERIMENTAL

This study is to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with Relapsed/Refractory Multiple Myeloma.

Biological: BCMA-PD1-CART Cell

Interventions

BCMA-PD1-CART CellBIOLOGICAL

This study was a single-center, open-label, single-arm, non-randomized clinical trial, which was divided into 3 groups by infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patient in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, we select the safest dose and recruit more patients for CART test to explore its effectiveness.

multiple myeloma

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 14 to 80 years (including 14 and 80 years old).
  • The diagnosis was Refractory/relapsed multiple myeloma.(Meeting 1 of the follow 3 items)
  • A.Primary treatment patients with no effect after first and second line treatment.
  • B.Patients who relapsed after complete remission and failed to respond to two kind of therapy.
  • C.the predicted survival is more than three months.
  • Flow cytometry or immunohistochemistry showed BCMA positive in tumor cells.
  • Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
  • No serious concomitant disease and major organ function is not serious abnormal.
  • No serious concomitant disease and major organ function is not serious abnormal.
  • the test meets the following indicators:
  • A.ALT/AST \< 2.5 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L.
  • B.WBC≥2.5×109/L.
  • C.PT/INR \< 1.7 or PT was extended by less than 4 seconds.

You may not qualify if:

  • Women who are pregnant or breastfeeding.
  • Transduced positive T lymphocytes \< 5% or amplified against CD3/CD28 stimulation \< 5 times.
  • Active hepatitis B or hepatitis C, HIV/AIDS infection, any uncontrolled active infection.
  • Patients who are using steroid drugs throughout the body currently.
  • Patients who have received any gene therapy in the past.
  • Patients who are allergy to immunotherapy and related drugs.
  • Patients with heavy heart disease or poorly controlled high blood pressure.
  • Patients who received chemotherapy or radiation 4 weeks before the study began.
  • Patients who are participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hainan Hospital of Chinese PLA General Hospital

Sanya, Hainan, 572000, China

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellPlasmacytoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Quanshun Wang

    Hainan Hospital of Chinese PLA General Hospital

    STUDY CHAIR

  • Wenshuai Zheng

    Hainan Hospital of Chinese PLA General Hospital

    STUDY DIRECTOR

  • Lixun Guan

    Hainan Hospital of Chinese PLA General Hospital

    STUDY DIRECTOR

  • Lu Wang

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Yuanyuan Xu

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Zhenyang Guan

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanshun Wang

CONTACT

15692538521wqs63@sohu.com

Wenshuai Zheng

CONTACT

1570157262818766179210@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study was a single-center, open-label, single-arm, non-randomized clinical trial, which was divided into 3 groups by infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patient in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, we select the safest dose and recruit more patients for CART test to explore its effectiveness.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Hematology Department of Hainan Hospital of PLA General Hospital; Vice Chief of Hematology Department of PLA General Hospital

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 14, 2019

Study Start

July 7, 2019

Primary Completion

October 10, 2021

Study Completion

October 10, 2022

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)