NCT05740891

Brief Summary

Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed 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
50

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Mar 2023

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

February 3, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 3, 2023

Last Update Submit

February 13, 2023

Conditions

Multiple Myeloma

Keywords

AHSCTBCMA CAR-T

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 \[Safety and Tolerability\]

    24 months after cell infusion

Secondary Outcomes (5)

  • overall response rate

    Up to 30 months

  • Complete response rate(CRR)

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

  • Overall survival (OS)

    Month 6,12,18and 24

  • Duration of response(DOR)

    Month 6,12,18and 24

  • Progression-free survival (PFS)

    Month 6,12,18and 24

Study Arms (1)

Treatment Group

EXPERIMENTAL

Refractory and relapsed multiple myeloma

Drug: BCMA CAR-T cells injection

Interventions

BCMA CAR-T cells injectionDRUG

Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells

Treatment Group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 、BCMA positive accompanied by refractory/relapsed and resistance;
  • 、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation;
  • 、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing;
  • 、Repeated MRD (+) refractory drug resistant cases;
  • 、Male or female, 30-75 years old;
  • 、Anticipated survival time more than 12 weeks
  • 、Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
  • 、Those who 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 of medical college of 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

+8613605714822hehuangyu@126.com

Yongxian Hu, MD

CONTACT

+8615957162012huyongxian2000@aliyun.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
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 23, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

CN(1)