ISRCTN13777452进行中（未招募）1 期
Treating multiple myeloma and diffuse large B cell lymphoma by targeting the NF-?B pathway with the first-in-class GADD45ß/MKK7 inhibitor, DTP3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Disease-specific inclusion criteria (MM):
- •1. Documented diagnosis of multiple myeloma (IMWG 2014 criteria)
- •2. Any R-ISS stage
- •3. Measurable disease as determined by at least one of:
- •3.1. Serum M-protein =500 mg/dL
- •3.2. Urine M-protein =200 mg/24 hour
- •3.3. Involved serum free light chain (sFLC) level =10 mg/dL, provided that serum sFLC ratio is abnormal
- •4. Has previously been treated with an ImiD, a proteasome inhibitor and an anti-CD38 antibody
- •5. Previous treatment with at least two prior regimens
- •6. Relapsed (after most recent regimen) or refractory disease [refractory defined as either best response of progression on previous regimen or progression within 6 months of achieving PR (or better) on previous regimen]
- •7. Requires active therapeutic intervention (in the judgement of the investigator)
- •8. Not currently a candidate for stem cell transplantation or CAR T-cell therapy
- •Disease-specific inclusion criteria [DLBCL]:
- •9. Documented diagnosis of DLBCL [WHO 2016 criteria]
- •9.1. Diffuse large B-cell lymphoma – de novo or transformed (from follicular lymphoma only)
- •9.2. High-grade B-cell lymphoma (MYC with BCL2 and/or BCL6); High-grade B-cell lymphoma (NOS)
- •9.3. Primary mediastinal B-cell lymphoma
- •10. Non-GCB by local IHC [Dose Expansion Only]
- •11. Measurable disease as determined by CT (or MRI) documentation of two or more clearly demarcated lesions/nodes with a long axis >1.5 cm and short axis >1.0 cm or one clearly demarcated lesion/node with a long axis >2.0 cm and short-axis =1.0 cm AND baseline FDG-PET scans must demonstrate positive lesion compatibility with CT (or MRI) defined anatomical tumour sites
- •12. No available standard of care therapeutic regimens in the opinion of the investigator
- •13. Relapsed (after most recent regimen) or refractory disease [refractory defined as either best response of progression on previous regimen or progression within 6 months of achieving PR (or better) on previous regimen]
- •14. Requires active therapeutic intervention (in the judgement of the investigator)
- •15. Not currently a candidate for stem cell transplantation or CAR T-cell therapy
- •General inclusion criteria:
- •16. Adequate hematologic function:
- •16.1. ANC = 1 x 10e9/l (no restriction on prior growth factor support)
- •16.2. Platelet count =50 x 10e9/l (no platelet transfusions permitted in 7 last days prior to assessment). Platelet counts of <50 x 10e9/l may be considered, on a case by case basis, for patients with significant malignant bone marrow involvement, after discussion with the medical monitor
- •16.3. Hb =8 g/dl (no RBC transfusions permitted in 7 last days prior to assessment)
- •16.4. aPTT and PT within institutional normal range (unless the patient is on full-dose warfarin, in which case INR within normal institutional therapeutic range is acceptable)
- •17. No evidence of bleeding diathesis or coagulopathy
- •18. Adequate laboratory biochemical function:
- •18.1. Serum creatinine =1.5 x ULN OR creatinine clearance =30 ml/min (Cockcroft-Gault calculation)
- •18.2. Bilirubin level <1.5 X ULN
- •18.3. AST and ALT <2.5 X ULN
- •19. ECOG performance status 0-2
- •20. Age >16 years
- •21. Written informed consent prior to admission into the study
排除标准
- •1. Primary or secondary CNS lymphoma
- •2. T-cell rich B-cell lymphoma
- •3. Plasma cell leukaemia
- •4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •5. Primary amyloidosis
- •6. Clinically significant (in the opinion of the investigator) cardiovascular disease, such as:
- •History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty/stenting/bypass grafting within the past 6 months prior to the date of consent
- •Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- •Severe cardiac arrhythmia requiring medication or severe conduction abnormalities
- •Poorly controlled hypertension (resting diastolic blood pressure >100 mmHg)
- •Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy, QTc prolongation [defined as a QTc interval >450 msec (males) or >470 msec (females)] or other significant ECG abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate <50 beats/min)
- •7. Clinically significant (in the opinion of the investigator) cerebrovascular disorders or vascular dementia
- •8. Clinically significant (in the opinion of the investigator) intercurrent medical or psychiatric illness, including serious active infection
- •9. Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain)
- •10. Concurrent treatment with other experimental drugs
- •11. A daily requirement for prednisone at a dose of >10 mg/day (or steroid equivalent) at time of starting the first dose of study drug. Higher doses are permitted for primary disease symptomatic control during the screening period, after discussion with the medical monitor, but this must have been tapered to a dose of =10 mg/day by the time treatment with DTP3 starts
- •12. Sem cell transplant (autologous/allogeneic) or CAR T-cell regimen within 12 weeks of the date of consent
- •13. Participation in another clinical trial with any investigational drug within 28 days prior to the date of consent
- •14. Prior (non-experimental) MM or DLBCL therapy within 28 days of the date of consent. Concomitant bisphosphonate therapy is permitted
- •15. Prior radiotherapy within 28 days of the date of consent. Localised palliative radiation therapy to a single site for symptomatic control is acceptable within this period
- •16. Anticipated need for concurrent radiotherapy during the study
- •17. Past or current history of other neoplasms, except for:
- •17.1. Curatively treated non-melanoma skin cancer
- •17.2. Adequately treated in situ carcinoma of the cervix
- •17.3. Prostate adenocarcinoma with documented PSA value of <0.1 ng/ml within 6 weeks of the date of consent
- •17.4. Other cancer curatively treated and with no evidence of disease for at least 3 years before the date of consent.
- •18. Known HIV infection
- •19. Active hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result
- •20. Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception:
- •20.1. Oral, injected or implanted hormonal contraception and condom
- •20.2. Have an intra-uterine device and condom
- •20.3. Vasectomised partner
- •20.4. Sexual abstine
研究者
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