NCT03271632

Brief Summary

The aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

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
20

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

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 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

August 27, 2017

Last Update Submit

September 18, 2019

Conditions

Multiple Myeloma

Keywords

multiple myelomachimeric antigen receptorBCMACD38CD56CD138

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with treatment related adverse effect

    percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.

    1 month

Secondary Outcomes (2)

  • Anti-tumor activity of fourth generation multiple CAR-T cells after infusion

    1 year

  • Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM

    1 year

Study Arms (1)

Single arm

EXPERIMENTAL

CAR T cells to treat MM

Biological: CAR T cells

Interventions

CAR T cellsBIOLOGICAL

Infusion of multi-CAR T cells

Single arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT).
  • Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens.
  • MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor.
  • Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
  • Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
  • Residual disease after primary therapy and not eligible for ASCT
  • Expected survival \> 12 weeks
  • Creatinine \< 2.5 mg/dl
  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal
  • Bilirubin \< 2.0 mg/dl
  • Any relapse after prior SCT is eligible regardless of other prior therapy
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Voluntary informed consent is given

You may not qualify if:

  • Pregnant or lactating women
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation
  • HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

The First People's Hospital of Yunnan

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Immunotherapy, Adoptive

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)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Lung-Ji Chang

    Shenzhen Geno-Immune Medical Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang

CONTACT

86-075586725195c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2017

First Posted

September 5, 2017

Study Start

July 15, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)