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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537442
• Other study ID #: Immunochina
• Status: Recruiting
• Phase: Phase 1
• Start date: September 3, 2020
• Est. completion date: March 2, 2023

Study information

• Verified date: August 2020
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: Fei Wu, MD
• Phone: +8615801390058
• Email: wufei[@]immunochina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• IM21 CAR-T cells
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

Locations

Country	Name	City	State
China	Beijing hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate(ORR) at 90 days		90days