NL-OMON51902
Recruiting
Not Applicable
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 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cancer of the lymphatic system
- Sponsor
- CellPoint B.V.
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \>\=
- •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
Outcomes
Primary Outcomes
Not specified
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