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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: IM21 CAR-T cells

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Hospital
      • Contact: Hui Liu, MD, PhD; Phone Number: 13520618812; Email: liuhui8140@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IM21 CAR-T cells; IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate(ORR) at 90 days	90days

Collaborators and Investigators

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Investigators: Principal Investigator: Hui Liu, MD, PhD, Beijing Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 3, 2020
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): March 2, 2023

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (ACTUAL): September 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Multiple myeloma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: Immunochina

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No