Clinical trial · Interventional
Impact of Treatment With Targeted Therapies on the Generation of CAR T Cells in CLL Patients
Impact of Treatment With Targeted Therapies on the Generation of Effective CAR T Cells in Patients With Chronic Lymphocytic Leukemia
NCT04640909CI-TRIAL-00055780unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this biological study, blood samples will be collected from patients with CLL treated with targeted agents (ibrutinib and venetoclax) to assess the impact of these treatments on the generation of CAR T cells in terms of manufacturing efficiency, immunophenotypic characteristics and functional properties.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood samples withdrawal | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CAR T Cells generation
- description
- CAR T Cells generation at baseline and after 6 and 12 months of treatment
- interventionNames
- Other: Peripheral blood samples withdrawal
Primary outcomes (1)
- measure
- Cell killing rate of anti-CD19 CAR T cells
- timeFrame
- After 12 months of treatment
- description
- Assessment of the cytotoxic functions of anti-CD19 CAR T cells generated from CLL patients in terms of cell killing rate before and during treatment with targeted agents (i.e. ibrutinib or venetoclax).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CLL/SLL meeting the IWCLL 2008 criteria; * ≥18 years old; * Indication for treatment with targeted therapies (i.e. ibrutinib or venetoclax); * Anticipated possibility to collect blood samples at the baseline and at 6- and 12-month timepoints; * Signed written informed consent according to ICH/EU/GCP and national local laws; * Confirmed availability of the laboratory to enroll and to process patient samples. Exclusion Criteria: * Expected treatment duration with targeted drug \< 12 months, according to treating physician; * Previously treated with more than 2 lines of CLL-directed therapy; * Concurrent use of systemic steroids or chronic use of immunosuppressive medications; * Active HBV (HBsAg+ or HBV DNA+) or HCV or HIV infection.
References
Publications (0)
Data not yet available
No reference posted for this study.