Status:
UNKNOWN
T Cells Expressing a Bispecific CAR Targeting CS1 and BCMA in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Wuhan Si'an Medical Technology Co., Ltd
Conditions:
CS1+ or BCMA+ Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of the bispecific CAR T cells targeting CS1 and BCMA in patients with relapsed or refractory multiple myeloma.
Detailed Description
* Multiple myeloma(MM) is one of the most common hematological malignancies with substantial morbidity and mortality. * In recent years, several new therapies have prolonged survival of patients with ...
Eligibility Criteria
Inclusion
- Each potential subject must meet all of the following criteria to be enrolled in the study:
- Aged 18-78 years old, males or females.
- Relapsed or refractory multiple myeloma according to IMWG diagnostic criteria.
- Received at least 2 prior lines of treatment for multiple myeloma, including a proteasome inhibitor and an immunomodulatory drug.
- Detectable MM cells in bone marrow by conventional morphologic methods or flow cytometry, and positive expression of CS1 or BCMA on MM cells as confirmed by immunohistochemistry or flow cytometry.
- Measurable diseases at screening as defined by any of the following:
- Serum M-protein level ≥1.0g/dL;
- Urine M-protein level ≥200mg/24 hours;
- Serum immunoglobulin free light chain(FLC) ≥10 mg/dL provided abnormal FLC ratio.
- Recovery to grade 1 or baseline of toxicities due to prior treatment, excluding hematologic toxicities and toxicity of no clinical significance, like alopecia.
- ECOG Performance Status 0 \~ 2 (ECOG status of larger than 2 points caused by MM osteolytic destruction is accepted).
- Good organ function at screening as defined by any of the following:
- AST and ALT ≤ 2.5×upper limit of normal (ULN);
- Total bilirubin≤ 2.0×ULN;
- Creatinine clearance ≥30 mL/min/1.73m2;
- Ejection fraction of heart ≥50%, and no clinically significant abnormal ECG findings.
- Clinical laboratory values meeting the following criteria at screening:
- Absolute Neutrophil Count(ANC) ≥1.0×10\^9/L;
- Platelets ≥30×10\^9/L;
- Absolute Lymphocyte Count ≥1.0×10\^8/L;
- Hemoglobin(Hb) ≥6.0g/dL.
- Women of childbearing potential must have a negative pregnancy test at screening.
- Patients with extramedullary lesions were eligible.
- Patients who received prior allogeneic or autologous stem cell transplantation at least three months before screening were eligible.
- Sign the informed consent voluntarily.
Exclusion
- Any potential subject who meets any of the following criteria will be excluded from participating in the study:
- Evidence of serious viral, bacterial, or uncontrolled systemic fungal infection.
- Seropositive for human immunodeficiency virus (HIV) antibody.
- Seronegative for hepatitis B antigen or a known history of hepatitis B.
- Hepatitis C (anti-hepatitis C virus \[HCV\] antibody positive or HCV-RNA quantitation positive) or a known history of hepatitis C.
- Systemic corticosteroid therapy of greater than 5 mg/day of prednisone or equivalent dose within 2 weeks prior to apheresis.
- Active autoimmune disease or a history of autoimmune disease within 3 years.
- The following cardiac conditions: Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment; History of clinically significant ventricular arrhythmia or unexplained; New York Heart Association stage III or IV congestive heart failure.
- A history of epilepsy or other central nervous system diseases or altered mental status.
- Known life-threatening allergies, hypersensitivity, or intolerance to CAR-T cells or relevant lymphodepleting regimens (cyclophosphamide and fludarabine).
- Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within one year after receiving study treatment.
- Any uncontrolled diseases, other than multiple myeloma, that may lead to abnormal death.
- Being participating in other intervention studies.
- Other cases excluded by the Investigators.
Key Trial Info
Start Date :
March 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04662099
Start Date
March 25 2020
End Date
December 30 2023
Last Update
August 16 2023
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022