Acute Myeloid Leukaemia Clinical Trial
Official title:
WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid
leukaemia.
Patient's white blood cells (T cells) are modified to specifically fight the leukaemia cells
by transferring a gene into the T cells, which allows them to recognize fragments of a
protein called WT1. This protein is present on the surface of leukaemia cells at very high
levels. The gene transferred to the T cells enables them to make a new T cell receptor (TCR),
which will allow them to attack leukaemia cells with high levels of WT1 on their surface.
Using this form of gene therapy the investigators can convert some of the patient's immune
system's own T cells into T cells that the investigators hope will be much more effective at
recognizing and killing leukaemia cells.
This trial concerns a novel approach to generating leukaemia antigen-specific T cells for
adoptive cellular therapy in HLA-A*0201 patients with acute myeloid leukaemia (AML) and
chronic myeloid leukaemia (CML)
In this study, patient T cells will be gene-modified using a GMP grade retroviral vector
containing the genes for a WT1-specific, HLA-A2-restricted T cell receptor. This ex vivo gene
therapy will generate T cells expressing the WT1-specific TCR and thus able to recognise
WT1-expressing target cells.
The autologous Cys1 WT1 TCR-transduced T cells will be re-infused back into adult leukaemia
patients following lymphodepleting conditioning.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02272478 -
Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations
|
Phase 2/Phase 3 | |
| Completed |
NCT03672695 -
Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.
|
Phase 1 | |
| Completed |
NCT01019161 -
An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Completed |
NCT00530699 -
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Not yet recruiting |
NCT06326697 -
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Completed |
NCT01597219 -
Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers
|
Phase 2 | |
| Completed |
NCT01063660 -
Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)
|
Phase 2 | |
| Terminated |
NCT05712278 -
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1 | |
| Terminated |
NCT03217838 -
Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.
|
Phase 1 | |
| Withdrawn |
NCT04106076 -
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT04217278 -
A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT
|
Phase 2/Phase 3 | |
| Completed |
NCT02844257 -
Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia
|
N/A | |
| Active, not recruiting |
NCT01716364 -
Safety Study of Anti LewisY Chimeric Antigen Receptor in Myeloma, Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
| Recruiting |
NCT06345365 -
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
|
Phase 3 | |
| Completed |
NCT01422603 -
Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)
|
Phase 1/Phase 2 | |
| Completed |
NCT04629443 -
Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02189824 -
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
|
Phase 1 | |
| Recruiting |
NCT02724163 -
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
|
Phase 3 | |
| Completed |
NCT01236144 -
A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.
|
Phase 1/Phase 2 | |
| Completed |
NCT01497002 -
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
|
Phase 3 |