Study of SYS6020 in BCMA-positive Multiple Myeloma

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Incidence of adverse events (AEs) [Time frame: Up to approximately 6 months]
• Dose limiting toxicities (DLTs) [Time frame: Up to 21 days]

Secondary outcome measures (3)

• Overall response rate (ORR) [Time frame: Up to approximately 6 months]
• Percentage of subjects who achieved complete response or strict complete response (CR/sCR) [Time frame: Up to approximately 6 months]
• Percentage of subjects who achieved very good partial response (VGPR) and higher response rate [Time frame: Up to approximately 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06359509 · SYS6020-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗