Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma

This is a open-label to determine the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma.

Study Overview

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

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

Contacts and Locations

• Study Contact: Name: Fei Wu; Phone Number: +8615801390058; Email: wufei@imunopharm.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • Hospital of China Medical University
      • Contact: Xiaojing Yan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor .
• Evidence of cell membrane BCMA expression.
• Subjects must have measurable disease,including 1) Serum M-protein greater or equal to10 g/L. 2) Urine M-protein greater or equal to 200 mg/24 h. 3)Serum free light chain (FLC) assay: involved FLC level greater or equal to 100 mg/L provided serum FLC ratio is abnormal.
• ≥ 18 years of age at the time of signing informed consent.
• Estimated life expectancy >3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up.
• Adequate organ function.
• Voluntarily sign informed consent form(s).

Exclusion Criteria:

• Subjects with graft versus host disease and need to use immunosuppressive agents.
• Subjects who had received chemotherapy or radiotherapy within 3 days prior to the blood collection period.
• Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids)
• Subjects who had previously used any gene therapy product.
• Subjects with known central nervous system disease.
• Subjects with plasmacytic leukemia, Wallenian macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis.
• Subjects had the following cardiac conditions, including but not limited to unstable angina pectoris, myocardial infarction or coronary artery bypass graft in the 6 months prior to enrollment, severe arrhythmias with poor drug control;
• Subjects infected with active HBV or HCV, HIV, syphilis or other untreated active infections;
• Pregnant or lactating women.
• Subjects who have other uncontrolled diseases and are considered by the researchers to be unsuitable to participate in the study.
• Any situation that the researcher believes may increase the risk of subjects or interfere with the results of clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Incidence of treatment related AEs	Up to 28 days after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )	The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.	Up to 24 weeks after CAR-T cell infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	Up to 24 weeks after CAR-T cell infusion
Duration of Response (DOR)	Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)	Up to 24 weeks after CAR-T cell infusion
Minimal residual disease（MRD）	Up to 24 weeks after CAR-T cell infusion

Collaborators and Investigators

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Investigators: Principal Investigator: Xiaojing Yan, M.D., First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

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: YMCART201909

Drug and device information, study documents

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