NCT03711864

Brief Summary

In patients with multiple myeloma with recurrent or refractory BCMA, CAR-T cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10\^5 / kg, 1 x 10\^6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group).

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
15

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Feb 2019

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

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

October 17, 2018

Last Update Submit

September 28, 2020

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Occurrence of study related adverse events

    defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

    2 years

Study Arms (1)

IM21 CAR-T cells

EXPERIMENTAL

IM21 CAR-T cells

Biological: IM21 CAR-T cells

Interventions

IM21 CAR-T cellsBIOLOGICAL

fludarabine and cyclophosphamide Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days

Also known as: IM21
IM21 CAR-T cells

Eligibility Criteria

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

You may qualify if:

  • The patient had multiple myeloma (according to the updated IMWG diagnostic criteria)Active (symptomatic) myeloma
  • Refractory and recurrent multiple myeloma Refractory definition: 1) treated with at least second-line bortezomib or lenalidomide 2) determined by the clinician Definition of recurrence: refer to NCCN clinical guidelines for multiple myeloma (2016. V2), including recurrence after transplantation.
  • Age: 18 to 80 years old;
  • The expected survival time was more than 3 months;
  • ECoG score 0-2 (refer to Annex 2)
  • Hemoglobin (HB)≥80g/L; absolute neutrophil count (ANC)\>1×10\^9/L; platelet count(PLT)≥50×10\^9/L.
  • Those who voluntarily participated in the experiment and signed informed consent.

You may not qualify if:

  • High risk organ involvement patients: tumor invasion of central nervous system, gastrointestinal tract,lung,pericardium,one of the major vessels;
  • Those who have graft-versus-host reaction and need to use immunosuppressants, or who have autoimmune diseases;
  • Chemotherapy or radiotherapy was used within 3 days before blood collection;
  • Patients who used systemic steroids within 5 days before blood collection (except those who have recently or are currently using inhaled steroids);
  • The patients who used drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before the blood collection period;
  • Those who have previously used any gene therapy products;
  • History of epilepsy or other central nervous system diseases;
  • New York Heart Association (NYHA) grade III or above (refer to Annex 3) (for patients with heart disease, this assessment is required);
  • Creatinine \> 1.5 times normal upper limit, ALT / AST\>3 times normal upper limit or bilirubin \>2 times normal upper limit;
  • Active hepatitis B or hepatitis C virus, HIV or other uncured active infections;
  • Pregnant or lactating women;
  • Those who suffer from other uncontrolled diseases are not suitable to join the study; Any situation that the researchers believe may increase the risk of subjects or interfere with the test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, 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

  • Daobin Zhou, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Zhang, M.D.

CONTACT

+86-18610728815pumczhanglu@163.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
Attending doctor

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

February 25, 2019

Primary Completion

October 10, 2021

Study Completion

December 20, 2021

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

CN(1)