NCT04537442

Brief Summary

This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.

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
10

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Sep 2020

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

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

August 28, 2020

Last Update Submit

August 28, 2020

Conditions

Multiple Myeloma

Keywords

Multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events within 1 month after CAR-T cell infusion

    The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion

    30days

Secondary Outcomes (1)

  • Objective Response Rate(ORR) at 90 days

    90days

Study Arms (1)

IM21 CAR-T cells

EXPERIMENTAL

IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.

Drug: IM21 CAR-T cells

Interventions

IM21 CAR-T cellsDRUG

IM21 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days Other Names: Fludarabine Cyclophosphamide

IM21 CAR-T cells

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;
  • Age ≥60 years old;
  • The expected survival time is more than 3 months;
  • ECOG score is 0-2;
  • Those who voluntarily participate in the study and sign the informed consent;
  • Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) \>1×10\^9/L Total platelet count (PLT)≥35×10\^9/L;
  • left ventricular ejection fraction \> 45%.

You may not qualify if:

  • High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;
  • Those who have graft versus host disease and need to use immunosuppressive agents;
  • Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);
  • Active hepatitis B or C virus, HIV or other untreated active infected persons;
  • Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;
  • Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

  • Wang T, Yang Y, Ma L, Feng R, Li J, Zhang C, Bai J, Ding Y, Liu G, Wu F, Lu X, Feng S, Li Z, He T, Li J, Liu H. BCMA-BBZ-OX40 CAR-T Therapy Using an Instant Manufacturing Platform in Multiple Myeloma. J Immunother Cancer. 2024 Sep 23;12(9):e009476. doi: 10.1136/jitc-2024-009476.

    PMID: 39313307DERIVED

  • Wang T, He T, Ma L, Yang Y, Feng R, Ding Y, Shan Y, Bu B, Qi F, Wu F, Lu XA, Liu H. Clinical Outcomes of BCMA CAR-T Cells in a Multiple Myeloma Patient With Central Nervous System Invasion. Front Oncol. 2022 May 16;12:854448. doi: 10.3389/fonc.2022.854448. eCollection 2022.

    PMID: 35651792DERIVED

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

  • Hui Liu, MD, PhD

    Beijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu, MD

CONTACT

+8615801390058wufei@immunochina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

September 3, 2020

Primary Completion

December 30, 2022

Study Completion

March 2, 2023

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)