A long-term follow-up study for patients treated with Galapagos CAR T cell therapies

Phase 1

Conditions: Relapsed/refractory B-Cell non-Hodgkin lymphoma, Relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Relapsed/refractory multiple myeloma
MedDRA version: 21.0Level: LLTClassification code: 10051812Term: Small cell lymphocytic lymphoma Class: 10029104
MedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104
MedDRA version: 21.0Level: LLTClassification code: 10008976Term: Chronic lymphocytic leukemia Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-510173-34-00

Lead Sponsor: Galapagos

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Subject must be able and willing to comply with the clinical study protocol (CSP) requirements and must sign and date the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC) / Institutional Review Board (IRB), prior to any study-related procedures., All subjects who have been treated with a GLPG CAR T-cell therapy in a clinical trial or Managed Access Program.

Exclusion Criteria

There are no exclusion criteria for this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of GLPG CAR T cell products for up to 15 years post CAR T cell product infusion;Secondary Objective: To evaluate the long-term efficacy of GLPG CAR T-cell products for up to 15 years post CAR T-cell product infusion;Primary end point(s): The type and incidence of targeted adverse events (AEs), The type and incidence of serious AEs (SAEs) considered related to the GLPG CAR T-cell therapy, The incidence of detectable CAR transgene levels in peripheral blood, The pattern of vector integration sites, if at least 1% of T-cells in the blood sample or new malignancies are positive for vector sequences, The incidence of detectable replication-competent lentivirus (RCL) in peripheral blood, Cause of death

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Disease progression status;Secondary end point(s):Time to subsequent anticancer therapy;Secondary end point(s):Overall survival