Clinical trial · Interventional
T Regulatory Lymphocytes (Treg) Depletion for Cancer Treatment Efficacy and Safety Study
Controlled and Selective Depletion of Regulatory T-cell for Cancer Treatment, Efficacy and Safety Study
- 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)
T regulatory lymphocytes were shown to be partly responsible for immune tolerance to cancer cells. In that respect these cells oppose to the mounting of an efficacious immune response needed to cure cancer. To treat advanced metastatic colorectal cancer, the investigators propose an immunotherapy consisting in autologous lymphocytes infusion depleted from T-regulatory cells, associated with a 5-day prior lymphoid-ablative chemotherapy associating cyclophosphamide (day 1 \& 2) with fludarabine (day 1 to 5). To administer treatment and monitor chemotherapy safety, patients will be hospitalized for 3 weeks until complete recovery from chemotherapy. Patients will then be followed-up ambulatory for 9 months during which time they will be assessed for tumor size with computed tomography (CT) - scan (primary criteria).
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive autologous cell immunotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- adaptive cell immunotherapy
- interventionNames
- Biological: Adaptive autologous cell immunotherapy
Primary outcomes (1)
- measure
- Tumor size of hepatic and/or lung metastases, as measured with tomodensitometry (RECIST 1.1 criteria)
- timeFrame
- from Month 1 to Month 9
Secondary outcomes (5)
- measure
- MRI : Assessment of tumor necrosis, cellularity and morphological criteria RECIST 1.1 (functional criteria following injection : DCEMRI and diffusion MRI)
- timeFrame
- Month 1 to Month 9
- measure
- Sonography : assessment of vascular micro-circulation with contrast injection,
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Colon or rectal adenocarcinoma histologically proven; * Hepatic or lung metastasis (at least one with size \>1cm on CT-scan); * Not eligible for surgery; * Prior treatment with fluoropyrimidines, CPT11, oxaliplatine and EGFR antibodies (Cetuximab ou Panitumumab) ± bevacizumab; When tumor has a mutated Kras, prior treatment with EGFR antibodies is not mandatory; * No local recurrence (on CT-scan, sonogram and/or colonoscopy); * Karnofsky index \> 70 and PS 0 or 1; * ASA Score \< 3 ; * Absence of chronic hepatopathy ; * Lab test : WBC: neutrophil\> 2.0 109 / l, lymphocytes \> 1.5 109 / l; creatinine \< 1.5 x ULN or clearance ≥ 60 ml/min; AST et ALT\< 5 x ULN, alkaline phosphatases \< 3 x ULN; LDH \< 3 x ULN; negative Coombs test ; * Signed informed consent. Exclusion Criteria: * Peritoneal carcinosis on CT-scan, MRI or PET-scan; * Contra-indication to MRI; * Patient with known allergy to iodinated contrast agent, gadolinium or Sulfate Hexafluoron ; * Presence of metastasis at sites other than lung and liver; * Documented history of auto-immune disease and/ or progressing disease; * Infection at whatever site; * Documented history of allo- or autograft; * Undernutrition, BMI \< 18; * History of other cancer \< 5 years (excluding cancer in situ of the cervix and baso-cellular tumor of the skin) or progressing disease; * Women of child bearing age without contraception , or pregnant or breast feeding.
References
Publications (0)
Data not yet available