Back to results

Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IM21 CAR-T cells

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IM21 CAR-T cells

Arm Description

IM21 CAR-T cells

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03711864

First Posted

October 17, 2018

Last Updated

September 28, 2020

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Immunochina Medical Science & Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03711864

Brief Title

Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

Official Title

Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 25, 2019 (Actual)

Primary Completion Date

October 10, 2021 (Anticipated)

Study Completion Date

December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Immunochina Medical Science & Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

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). If DLT occurs in 1 of the 3 patients (with or without) or 2 of the 6 patients (with or without), no further dose escalation is allowed. Researchers and bidders to form drug safety monitoring committee (SRC), every dose group of subjects to complete the DLT observation period, after summarizing the security of this dose group, determine the test of the next dose, subjects such as draw up the highest dose group safety tolerance, SRC to decide whether to continue to increase the dose group of research, finally according to have obtained all the safety and efficacy of dose group information to determine the recommended dose (RP2D).Dose-limiting toxicity (DLT)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IM21 CAR-T cells

Arm Type

Experimental

Arm Description

IM21 CAR-T cells

Intervention Type

Biological

Intervention Name(s)

IM21 CAR-T cells

Other Intervention Name(s)

IM21

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of study related adverse events

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Zhang, M.D.

Phone

+86-18610728815

pumczhanglu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daobin Zhou, M.D.

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100005

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Li, M.D.

Phone

+86-18610852525

lijian@pumch.cn

First Name & Middle Initial & Last Name & Degree

Lu Zhang, M.D.

Phone

+86-18610728815

pumczhanglu@163.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

We'll reach out to this number within 24 hrs