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Clinical Trials/EUCTR2021-003272-13-NL
EUCTR2021-003272-13-NL
Active, not recruiting
Phase 1

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 sites45 target enrollmentJune 24, 2021
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ConditionsRelapsed/refractory B-cell non-Hodgkin lymphomaMedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Relapsed/refractory B-cell non-Hodgkin lymphoma
Sponsor
CellPoint B.V.
Enrollment
45
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 24, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CellPoint B.V.

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 if due to underlying disease)
  • •7\. 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

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 malignancy other than lymphoma (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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