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

Recruiting

Conditions: cancer of the lymphatic system
Lymphoma
10025320

Registration Number: NL-OMON51902

Lead Sponsor: CellPoint B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints of the study:<br /><br># Phase I: Incidence of (S)AEs, including dose-limiting toxicities (DLTs) until<br /><br>D28<br /><br># Phase II: ORR until 2 years post 19CP02 dose per Lugano classification</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints of the study:<br /><br># Type, frequency and severity of AEs<br /><br># Objective response rate (ORR) until 2 years post 19CP02 dose per Lugano<br /><br>classification, Duration of response (DOR), Metabolic complete response rate<br /><br>(mCR), Event-free survival (EFS), Progression-free survival (PFS), Overall<br /><br>survival (OS), Minimal Residual Disease (MRD)<br /><br># Levels of anti-CD19 CAR T cells in blood, bone marrow, CSF, and other<br /><br>tissues, if available<br /><br># Levels of chemokines and cytokines in serum over time<br /><br># Number of successfully manufactured 19CP02 products within the predefined<br /><br>release specifications</p><br>