Study of SYS6020 in BCMA-positive Multiple Myeloma

A Phase І Study of BCMA-targeted Chimeric Antigen Receptor T Cell (SYS6020) Injection in Relapsed or Refractory Multiple Myeloma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Biological: BCMA Targeted CAR T-cells

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. ≥ 18 years of age at the time of signing informed consent;
• 2. Cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to IMWG criteria);
• 3. Bone marrow specimens confirmed positive BCMA expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (>5%);

• 4. 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)
• 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• 6. Diagnosis of MM with relapsed or refractory disease and have had at least 1 prior lines of therapy.

Exclusion Criteria:

• 1. Patients with plasmacytic leukemia or Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organ enlargement, endocrinopathy, monoclonal protein and skin lesions) or amyloidosis at screening;
• 2. Received any prior CAR-T therapy or BCMA targeted therapy;
• 3. Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to monocyte collection or history of allogeneic stem cell transplantation;
• 4. A history of immunodeficiency, including a positive HIV antibody test;
• 5. 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);
• 6. 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;
• 7. History of Bacillus Tuberculosis (TB) treatment within 2 years prior to first medication;
• 8. Patients with a history of interstitial lung disease and/or severe lung function impairment;
• 9. Have an active bacterial, fungal, or viral infection;
• 10.A history of severe cardiovascular disease.

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: SYS6020; Low, medium and high doses of SYS6020 will be given.	Biological: BCMA Targeted CAR T-cells; Each patient will receive BCMA Targeted CAR T-cells by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Overall response rate (ORR)	Up to approximately 6 months
Percentage of subjects who achieved complete response or strict complete response (CR/sCR)	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	Percentage of subjects who achieved very good partial response (VGPR) and higher response rate	Up to approximately 6 months

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• 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: SYS6020-001

Drug and device information, study documents

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