A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma - Atalanta-1

CellPoint B.V.0 个研究点目标入组 45 人开始时间: 2021年7月2日最近更新: 2024年2月26日

试验速览

暂无简介。

•1. Signed informed consent form
•2. Age = 18 years
•3. Histologically confirmed diagnosis of one of the following non-Hodgkin lymphoma subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, or MCL
•4. Relapsed or refractory disease
•5. Measurable disease according to the Lugano classification
•6. ECOG performance status of 0-2 (Subjects with ECOG 2 must have serum albumin = 3.4 g/dL)
•7 & 8. Adequate bone marrow, renal, hepatic and pulmonary function
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. Primary CNS B-cell lymphoma, Burkitt lymphoma, or Richter's transformation
•2. Selected prior treatments as defined in the protocol
•3. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 3 years (exceptions per protocol)
•4. Active CNS involvement (with neurological changes) by disease under study
•5. Infection with HIV, hepatitis B or hepatitis C virus

发起方

CellPoint B.V.