NCT05712083

Brief Summary

Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed 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
40

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_2 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

Study Start

First participant enrolled

January 30, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 21, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

January 31, 2023

Last Update Submit

February 17, 2023

Conditions

Multiple MyelomaNew Diagnosis Tumor

Keywords

BCMA CAR-TMultiple MyelomaNew Diagnosis

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT)

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

    Baseline up to 28 days after BCMA CAR T-cells infusion

  • Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

    Baseline up to 2 years after BCMA CAR T-cells infusion

Secondary Outcomes (4)

  • Multiple Myeloma (MM), Overall response rate (ORR)

    At Month 1, 3, 6, 12, 18 and 24

  • Complete response rate(CRR)

    Baseline up to 2 years after BCMA CAR T-cells infusion

  • Partial response Rate (PRR)

    Up to 2 years after BCMA CAR T-cells infusion

  • Overall survival

    Up to 2 years after BCMA CAR T-cells infusion

Study Arms (1)

Treatment Group

EXPERIMENTAL

This is a single arm clinical trial.

Drug: BCMA CAR-T cells

Interventions

BCMA CAR-T cellsDRUG

Each subject receive BCMA CAR T-cells by intravenous infusion

Also known as: BCMA CAR-T cells injection
Treatment Group

Eligibility Criteria

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

You may qualify if:

  • Age and gender unlimited;
  • According to the IMWG2014 standard, diagnosis as multiple myeloma;
  • According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
  • Abnormal plasmocyte BCMA expression positive;
  • Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
  • The subject has no lung activity infection;
  • Expected life time is more than 3 months;
  • ECOG score 0-2 score;
  • Voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

  • Patients with the history of epilepsy or other CNS disease;
  • Patients with prolonged QT interval time or severe heart disease;
  • Pregnant or breastfeeding;
  • Active infection with no cure;
  • Patients with active hepatitis B or C infection;
  • Previously treated with any genetic therapy;
  • The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  • Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
  • Those who suffer from other uncontrolled diseases are not suitable to join the study;
  • HIV infection;
  • Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

  • He Huang, MD

    First Affiliated Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

86-13605714822hehuangyu@126.com

Mingming Zhang, MD

CONTACT

13656674208mingmingzhang@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 3, 2023

Study Start

January 30, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

February 21, 2023

Record last verified: 2023-01

Locations

CN(1)