Clinical trial · Interventional
CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
Trial of Immune Reconstitution With CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
- 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)
The purpose of this research study is to test whether giving T-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to normal faster after chemotherapy. This research study will also look into the ability of the lab to process the T-cells for infusion and the side effects of giving T-cells to patients with chronic lymphocytic leukemia (CLL).
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infusion of CD3/CD28 stimulated T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- interventionNames
- Biological: Infusion of CD3/CD28 stimulated T cells
Primary outcomes (3)
- measure
- The occurrence of treatment-related adverse events or treatment related trial discontinuations, defined as NCI CTC ≥ grade 3 and clinical events that are possible, likely, or definitely related to study treatment at any time
- timeFrame
- Two years
- measure
- The ability to complete the outlined course of therapy
- timeFrame
- Two years
- measure
- The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients
- timeFrame
- Two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow. * Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II * Zubrod performance status of 0-3 * Prior treatment with fludarabine or alemtuzumab based regimens. * No untreated or uncontrolled life-threatening infection * Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study * No active CNS disease * Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies. Exclusion Criteria: * Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration * History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g. idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
References
Publications (0)
Data not yet available