Relapsed/refractory B-cell non-Hodgkin lymphoma MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: 19CP02
Product Code: 19CP02
Pharmaceutical Form: Dispersion for infusion
INN or Proposed INN: anti-CD19 CAR T cells
Current Sponsor code: 19CP02
Other descriptive name: 19CP02
Concentrat
Sponsors
CellPoint B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Type, frequency and severity of AEs 2. Objective response rate (ORR) until 2 years post 19CP02 dose per Lugano classification Duration of response (DOR) Metabolic complete response rate (mCR) Event-free survival (EFS) Progression-free survival (PFS) Overall survival (OS) Minimal Residual Disease (MRD) 3. Levels of anti-CD19 CAR T cells in blood, bone marrow, CSF, and other tissues, if available 4. Levels of chemokines and cytokines in serum over time 5. Number of successfully manufactured 19CP02 products within the predefined release specifications;Timepoint(s) of evaluation of this end point: The primary analyses will be conducted when all subjects have completed at least one response assessment. Final study report will be conducted when all subjects have completed the study (after LVLS). | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: Evaluate the safety of 19CP02 and determine the recommended Phase 2 dose Phase II: Evaluate the efficacy of 19CP02 in the different NHL subtypes;Secondary Objective: 1. Evaluate safety of 19CP02 2. Evaluate efficacy of 19CP02 3. Evaluate 19CP02 pharmacokinetics 4. Evaluate 19CP02 pharmacodynamics 5. Evaluate feasibility of 19CP02 manufacturing;Primary end point(s): Phase I: Incidence of (S)AEs, including dose-limiting toxicities (DLTs) until D28 Phase II: ORR until 2 years post 19CP02 dose per Lugano classification ;Timepoint(s) of evaluation of this end point: Safety (including DLTs) and efficacy data are reviewed on a continuous basis throughout the study. After completion of Phase I, safety and efficacy data will be evaluated to determine the RP2D. The primary analyses will be conducted when all subjects have completed at least one response assessment. Final study report will be conducted when all subjects have completed the 2 years disease response assessment, are lost to follow-up, withdraw from the study, or die, whichever occurs first. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactRegulatory
CellPoint B.V.
Outcome results
None listed