Clinical trial · Interventional
Infection and Tumour Antigen Cellular Therapy
A Clinical Trial of Donor-derived WT1 Specific T Cells for Prevention of Relapse in Combination With Multiple Pathogen Specific T Cells for Prevention of Infection in Patients Undergoing Allogeneic Haemopoietic Stem Cell Transplant for AML
- 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)
This study is to test a new therapy for patients with acute myeloid leukaemia who are undergoing blood stem cell transplant. In this study, the investigators will take a small number of your immune cells whose normal function is to give immunity to infections and help to fight leukaemia. These cells will be stimulated to multiply in the laboratory and will then be given to the transplant recipient after the transplant. This is a sort of "immunity transplant". The exact purpose of this study is to investigate if these cells are safe and effective in patients having a transplant for AML.
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 |
|---|---|---|---|
| Leukemia, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donor-derived WT1-CTL and P-CTL | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplant Recipient
- description
- The T cell product administration is personalized cellular therapy product, individually prepared for each participant. Donor-derived WT1-CTL and P-CTL. It's exact make up and effect is dependent on both donor and recipient characteristics and as such variability is expected in the response. These variations will be adjusted for by multiple samplings over time and collation and analysis of response in both individuals an the group as a whole. One infusion of 2 x 107/m2 P-CTLs prophylactically on or after day 28 post-allogeneic peripheral blood haemopoietic stem cell transplant (HSCT), combined with up to four infusions of 2x107/m2 WT1-CTLs.
- interventionNames
- Biological: Donor-derived WT1-CTL and P-CTL
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 2 Years
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing myeloablative or non-myeloablative allogeneic transplantation from an HLA (A, B and DR) identical or 1-3 antigen mismatched family or unrelated donor 2. Transplant performed for acute myeloid leukaemia 3. Leukaemia blasts express the WT1 tumour antigen as determined by the European LeukaemiaNet standardised assay described in 16. WT1 overexpression will be defined by greater than 250 copies/104ABL copies in bone marrow samples or greater than 50 copies/104ABL copies in peripheral blood. This assay will be performed on samples collected as part of routine clinical care at diagnosis and during initial treatment prior to transplantation. Testing will be performed after consent for trial participation has been obtained and negativity for WT1 will be classified as screening failure 4. Recipients of peripheral blood HSCT 5. Adequate hepatic and renal function (\< 3 x upper limit of normal for AST, ALT, \< 2 x upper limit of normal for total bilirubin, serum creatinine) 6. Estimated life expectancy of at least 12 months 7. Patient (or legal representative) has given informed consent Exclusion Criteria: 1. Use of anti-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum lymphocyte antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks after infusion 2. Grade II or greater graft versus host disease within 1 week prior to infusion 3. Prednisone or methylprednisone at a dose of \> 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion 4. Prior allogeneic HSCT 5. Privately insured in or outpatients (see Indemnity Issues, Section 11.4)
References
Publications (0)
Data not yet available