Phase I / II study of dose escalation and expansion to cohorts, with the therapeutic antibody 14F7h (Anti-NGlicolilGM3) in patients with chronic B-cell lymphoproliferative syndrome, refractory or relapsing

Center of Molecular Immunology (CIM)0 个研究点目标入组 142 人开始时间: 2018年3月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Dose comparison. Assignment: Other. Purpose: Treatment

•1. Refractory or relapsing B-cell cell lymphoproliferative syndrome, ganglioside NGlicolilGM3 (NGGM3) positive.
•2. Age =18 years, any gender and race.
•3. ECOG = 3.
•4. Life expectancy of 6 months.
•5. No candidates for transplant of hematopoietic progenitors or immunochemotherapy schemes not previously used.
•6. Four or more weeks from the previous specific therapy (QT, RT, biological therapies) (applicable to patients’ refractory to the previous treatment).
•7. Patients with laboratory parameters as detailed below: Hemoglobin = 80 g / L, Absolute neutrophil count = 1.5 x 109 / L, Platelet count = 75 x 109 / L, Liver function (bilirubin, ASAT or ALAT = 2.5 times the normal reference range of each institution), Renal function preserved (creatinine clearance =45 mL / min according to the Cockcroft and Gault formula).
•8. Voluntary signature of the informed consent model.
•9. Subjects of childbearing age and sexually active should agree to use a method of contraception during treatment (criteria valid only for patients of childbearing age).

•1. Pregnant, puerperal or breastfeeding
•2. Cytopenia of uncontrolled immune cause
•3. Active infection or known positivity for HIV, hepatitis B or C virus
•4. Heart failure grade III / IV according to NYHA criteria (New York Heart Association)
•5. Chronic decompensated diseases such as: arterial hypertension, diabetes mellitus, ischemic cardiopathy or other symptomatic cardiovascular diseases, epilepsy, obstructive pulmonary disease.
•6. Acute allergic states or known hypersensitivity to any component of the formulation under study.
•7. Obvious mental disability or other limitation that prevents the patient from signing their consent or hinders the evaluation of the study.
•8. Being receiving another research product.
•9. Another clinically active neoplasm that needs specific treatment (except basal cell carcinomas or cutaneous carcinomas in situ).

发起方

Center of Molecular Immunology (CIM)