cancer of the lymphatic system Lymphoma
Conditions
Interventions
# Leukapheresis of mononuclear cells
# Lymphodepletion chemotherapy regimen for 3 days consisting of
Cyclophosphamide IV 300 mg/m2/day and Fludarabine IV 30 mg/m2/day
# Infusion of 19CP02 consisting
Sponsors
CellPoint B.V.
Eligibility
Age
18 Years to 99 Years
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 or 1 (ECOG 2 is allowed when serum albumin >= 3.4 g/dL) 7. Adequate bone marrow, renal, hepatic and pulmonary function
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
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints of the study: # 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of the study: # Type, frequency and severity of AEs # 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) # Levels of anti-CD19 CAR T cells in blood, bone marrow, CSF, and other tissues, if available # Levels of chemokines and cytokines in serum over time # Number of successfully manufactured 19CP02 products within the predefined release specifications | — |
Countries
Netherlands
Outcome results
None listed