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Trial Title:
Study of SYS6020 in BCMA-positive Multiple Myeloma
NCT ID:
NCT06359509
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
BCMA Targeted CAR T-cells
Description:
Each patient will receive BCMA Targeted CAR T-cells by intravenous infusion.
Arm group label:
SYS6020
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2024
Completion date:
May 2032
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06359509
