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Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IM21 CAR-T cells
Sponsored by
Beijing Immunochina Medical Science & Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Beijing hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IM21 CAR-T cells

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective Response Rate(ORR) at 90 days

Full Information

First Posted
August 28, 2020
Last Updated
August 28, 2020
Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04537442
Brief Title
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
Official Title
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2020 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
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
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IM21 CAR-T cells
Arm Type
Experimental
Arm Description
IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
Intervention Type
Drug
Intervention Name(s)
IM21 CAR-T cells
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of adverse events within 1 month after CAR-T cell infusion
Description
The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion
Time Frame
30days
Secondary Outcome Measure Information:
Title
Objective Response Rate(ORR) at 90 days
Time Frame
90days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Wu, MD
Phone
+8615801390058
Email
wufei@immunochina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, MD, PhD
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Liu, MD, PhD
Phone
13520618812
Email
liuhui8140@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35651792
Citation
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.
Results Reference
derived

Learn more about this trial

Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma

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