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

NCT05478343 | Unknown Early Phase 1

• 1 other identifier: YMCART201909
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Objective response rate (ORR)

  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

• Duration of Response (DOR)

  Up to 24 weeks after CAR-T cell infusion

Study Arms (1)

IM21 CAR-T cells

EXPERIMENTAL

Biological: IM21 CAR-T cells

Interventions

IM21 CAR-T cells BIOLOGICAL

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

IM21 CAR-T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Related Publications (1)

• Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

  PMID: 37192741 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xiaojing Yan, M.D.

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu

CONTACT

+8615801390058; wufei@imunopharm.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: May 6, 2021
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

CN (1)