NCT04194931

Brief Summary

This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or 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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 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

December 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

December 9, 2019

Last Update Submit

December 10, 2019

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

Relapsed and refractory multiple myeloma; CAR-T

Outcome Measures

Primary Outcomes (4)

  • Overall response rate (ORR)

    Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment

    2 year

  • minimal residual disease（MRD）

    Assessment of MRD negative overall response rate at 3 months of treatment

    2 year

  • Progression-free survival (PFS)

    Assessment of Progression-free survival (PFS) at 6 months of treatment

    2 year

  • Overall survival (OS)

    Assessment of overall survival (OS) at 6 months of treatment

    2 year

Secondary Outcomes (2)

  • Safety (incidence of adverse events defined as dose-limited toxicity)

    Study treatment until Week 24

  • Expression of CD19 CART cells

    2 year

Study Arms (1)

Mixed BCMA/CD19 CAR-T Transfer

EXPERIMENTAL

Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts

Biological: Autologous BCMA CAR-T cells and CD19 CAR-T cells

Interventions

Autologous BCMA CAR-T cells and CD19 CAR-T cellsBIOLOGICAL

Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.

Mixed BCMA/CD19 CAR-T Transfer

Eligibility Criteria

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

You may qualify if:

  • Male or female aged 18-70 years old
  • Estimated Survival time \> 12 weeks
  • Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
  • Chemotherapy failure or recurrent multiple myeloma
  • Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
  • Bilirubin\<2.0mg/dl
  • Karnofsky Performance Status\>50% at the time of screening
  • Adequate pulmonary, renal, hepatic, and cardiac function
  • Fail in autologous haemopoietic stem cell transplantation
  • Not suitable for stem cell transplantation conditions or abandoned due to conditions
  • Free of leukocytes removal contraindications
  • Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent

You may not qualify if:

  • The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
  • Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
  • The patient is an active hepatitis B or hepatitis C infection
  • Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
  • Abnormal vital signs
  • Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
  • Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
  • General infection or local severe infection, or other infection that is not controlled
  • Dysfunction in lung, heart, kidney and brain
  • Severe autoimmune diseases
  • Other symptoms that are not applicable for CAR-T

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nangchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

MeSH Terms

Conditions

RecurrenceMultiple Myeloma

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Fei LI, M.D.;Ph.D.

CONTACT

+86-139-7003-8386yx021021@sina.com

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
M.D.,Ph.D.

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

December 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

CN(1)