EUCTR2019-001264-30-IT进行中（未招募）1 期
A phase I/IIa clinical trial to assess feasibility, safety and antitumor activity of autologous SLAMF7 CAR-T cells in multiple myeloma - SLAMF7 CAR-T in multiple myeloma
niversitätsklinikum Würzburg0 个研究点目标入组 38 人开始时间: 2021年8月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent form
- •2. Patient is >=18 years of age
- •3. Patient is willing and able to adhere to the protocol requirements
- •4. Patient with diagnosis of MM who has been treated with at least 2 prior lines of treatment, including at least one cycle of high-dose chemotherapy with autologous hematopoietic stem cell transplantation if the patient was eligible, and exposure to an immunomodulatory imide drug (e.g. lenalidomide and/or pomalidomide), a proteasome inhibitor,
- •and/or an anti-CD38 antibody.
- •5. At least one of the following subcriteria must be measured in the patient:
- •- Serum M-protein greater or equal to 0.5 g/dL
- •- Urine M-protein greater or equal to 200 mg/24 h
- •- Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
- •- A biopsy-proven evaluable plasmacytoma
- •- Bone marrow plasma cells >10% of total bone marrow cells (>30% if bone marrow plasma cells are the only marker of measurable disease)
- •6. Patients previously treated with an anti-SLAMF7 antibody are eligible.
- •7. Karnofsky performance status >=60%. If patient has a Karnofsky performance status <60% (e.g. after a spinal cord injury) but is judged to be medically fit by the investigator, patient is eligible.
- •8. Female patients of childbearing potential must:
- •a) have a negative pregnancy test (blood) at screening.
- •b) either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective measures of contraception without interruption, from screening through 1 year following the IMP infusion. A highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and
- •correctly) must be practiced.
- •c) Agree to abstain from breast feeding during the study participation and for 1 year after the IMP infusion.
- •9. Male patients must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 1 year after IMP infusion, even if he has undergone
- •a successful vasectomy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. Patient has undergone a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning <=12 months prior to leukapheresis.
- •2. Patient has undergone a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning >12 months, and suffers on chronic Graft-versus-Host Disease and/or is on systemic immune-suppressants.
- •3. Patient with diagnosis of MM
- •a. in first relapse following an autologous stem cell transplantation or
- •b. in second relapse that subsequently achieves a complete response that is considered being a candidate for an allogeneic stem cell transplantation, unless the patient explicitly denies undergoing an allogeneic stem cell transplantation.
- •4. Patient has received anti-CD38 and/or anti-SLAMF7 antibodies <=8 weeks prior to leukapheresis.
- •5. Ongoing treatment with systemic immune-suppressants (e.g. systemic cyclosporine or systemic steroids at any dose).
- •6. Echocardiogram with left ventricular ejection fraction <45%.
- •7. Inadequate renal function defined by creatinine clearance <=45 mL/min using Cockcroft-Gault equation.
- •8. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) and total bilirubin >1.5 x ULN (unless due to Gilbert’s syndrome and direct bilirubin is <=1.5 x ULN; unless due to intrahepatic myeloma lesions as demonstrated by magnetic resonance imaging [MRI] or positron emission tomography [PET]/computed tomography [CT] not older than 4 weeks prior to screening).
- •9. International ratio (INR) or partial thromboplastin time (PTT) >1.5 x ULN, unless on a stable dose of anti-coagulant.
- •10. Evidence of human immunodeficiency virus (HIV) infection.
- •11. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV), excluding
- •- Patients who are hepatitis B surface antigen negative and HBV viral deoxyribonucleic acid (DNA) negative
- •- Patients who had hepatitis B but have received an antiviral treatment and show non-detectable viral DNA for 6 months
- •- Patients who are seropositive because of hepatitis B virus vaccine
- •- Patients with known HBV infection but undetectable HBV viral load and on anti-viral therapy to prevent HBV reactivation.
- •12. Seropositive for and with active viral infection with hepatitis C virus (HCV), excluding
- •- Patients who had hepatitis C but had received an antiviral treatment and show no detectable HCV viral ribonucleic acid (RNA) for 6 months.
- •13. Seropositive for syphilis on treponema pallidum hemagglutination test, excluding
- •- Patients with negative treponema pallidum antibody absorption test result
- •14. Patients with active infection (e.g. asymptomatic and symptomatic severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] infection) or other serious medical or psychiatric disorder on investigators decision.
- •15. Pregnant or lactating women.
- •16. Current or previous (within 30 days of enrollment) treatment with another IMP.
- •17. Known abuse of alcohol, drugs, or medicinal products.
- •18. Employees of the sponsor, or employees or relatives of the investigator.
研究者
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