Study of SYS6020 in BCMA-positive Multiple Myeloma

NCT06359509 | Not Yet Recruiting Early Phase 1

• 1 other identifier: SYS6020-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs)

  Incidence of adverse events (AEs)

  Up to approximately 6 months

• Dose limiting toxicities (DLTs)

  Dose limiting toxicities (DLTs)

  Up to 21 days

Secondary Outcomes (3)

• Overall response rate (ORR)

  Up to approximately 6 months

• Percentage of subjects who achieved complete response or strict complete response (CR/sCR)

  Up to approximately 6 months

• Percentage of subjects who achieved very good partial response (VGPR) and higher response rate

  Up to approximately 6 months

Study Arms (1)

SYS6020

EXPERIMENTAL

Low, medium and high doses of SYS6020 will be given.

Biological: BCMA Targeted CAR T-cells

Interventions

BCMA Targeted CAR T-cells BIOLOGICAL

Each patient will receive BCMA Targeted CAR T-cells by intravenous infusion.

SYS6020

Eligibility Criteria

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

You may qualify if:

• \. ≥ 18 years of age at the time of signing informed consent;
• \. Cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to IMWG criteria);
• \. Bone marrow specimens confirmed positive BCMA expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (\>5%);
• \. Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:
• Serum M-protein≥ 1 g/dL（≥10 g/L）
• Urine M-protein ≥ 200 mg/24 hour
• Involved serum free light chain (FLCs) level≥10 mg/dL with FLCs abnormal ratio (\<0.26或\>1.65)
• \. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• \. Diagnosis of MM with relapsed or refractory disease and have had at least 1 prior lines of therapy.

You may not qualify if:

• \. Patients with plasmacytic leukemia or Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organ enlargement, endocrinopathy, monoclonal protein and skin lesions) or amyloidosis at screening;
• \. Received any prior CAR-T therapy or BCMA targeted therapy;
• \. Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to monocyte collection or history of allogeneic stem cell transplantation;
• \. A history of immunodeficiency, including a positive HIV antibody test;
• \. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA above the lower limit of measurement or 1000 copies /mL (500 IU/mL), (whichever is lower), HCV antibody positive and HCV-RNA above the lower limit of measurement or 1000 copies /mL (whichever is lower);
• \. Patients who, in the judgment of the investigator, need but are unable to receive prophylactic treatment for Pneumocystis, Herpes Simplex Virus (HSV), or Herpes Zoster (VZV) prior to initiation of treatment, or Syphilis confirmatory positive;
• \. History of Bacillus Tuberculosis (TB) treatment within 2 years prior to first medication;
• \. Patients with a history of interstitial lung disease and/or severe lung function impairment;
• \. Have an active bacterial, fungal, or viral infection;
• A history of severe cardiovascular disease.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

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 Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proferssor Cheif Doctor

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 11, 2024

Record last verified: 2024-04