Study of SYS6020 in BCMA-positive Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06359509
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Wuhan Union Hospital, China
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Arms & Interventions

Arms

Experimental: SYS6020

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

Interventions

Biological: - BCMA Targeted CAR T-cells

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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