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Clinical Trials/CTIS2022-502661-23-00
CTIS2022-502661-23-00
Active, not recruiting
Phase 1

A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma - CP0201-NH

Galapagos0 sites40 target enrollmentNovember 23, 2022
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Galapagos
Enrollment
40
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 23, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Galapagos

Eligibility Criteria

Inclusion Criteria

  • •1\. Signed informed consent form, 2\. Age \= 18 years, 3\.1 Histologically confirmed diagnosis of one of the following non\-Hodgkin lymphoma subtypes: Aggressive DLBCL, FL grade 1, 2 or 3A, MZL, or MCL, BL, PCNSL, 4\.1 Relapsed or refractory disease, 5\.1 Measurable disease according to the Lugano classification or IPCG criteria for PCNSL, 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

Exclusion Criteria

  • •Richter's transformation, Selected prior treatments as defined in the protocol, 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), Active CNS involvement (with neurological changes) by disease under study, Infection with HIV, hepatitis B or hepatitis C virus

Outcomes

Primary Outcomes

Not specified

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