Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486051
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma
Sponsor:
Malaghan Institute of Medical Research
Organization:
Malaghan Institute of Medical Research
Study Overview
Official Title:
A Phase 2 Trial to Evaluate the Efficacy and Safety of WZTL-002 in Patients With Relapsed or Refractory Large B-cell Lymphoma ENABLE-2
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENABLE-2
Brief Summary:
The goal of this clinical trial is to learn if a new type of chimeric antigen receptor CAR T-cell therapy called WZTL-002 is effective and safe for the treatment large B-cell lymphomas LBCL that have not responded to or have come back after standard chemotherapy The main questions this trial aims to answer are
What is the likelihood of complete response of the lymphoma after WZTL-002 treatment
What is the risk of altered brain function neurotoxicity after WZTL-002
All eligible participants will receive WZTL-002 the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies
Participants will
Have a procedure to gather white blood cells
Receive chemotherapy to prepare for the CAR T-cells
Receive WZTL-002 CAR T-cells through a vein
Be monitored closely for the first 14 days for certain side effects
Have scans 28 days and 3 6 12 and 24 months after WZTL-002 CAR T-cells to check if the treatment has worked
What is the likelihood of complete response of the lymphoma after WZTL-002 treatment
What is the risk of altered brain function neurotoxicity after WZTL-002
All eligible participants will receive WZTL-002 the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies
Participants will
Have a procedure to gather white blood cells
Receive chemotherapy to prepare for the CAR T-cells
Receive WZTL-002 CAR T-cells through a vein
Be monitored closely for the first 14 days for certain side effects
Have scans 28 days and 3 6 12 and 24 months after WZTL-002 CAR T-cells to check if the treatment has worked
Detailed Description:
WZTL-002 is a third-generation CAR T-cell product comprising autologous T-cells transduced to express a CAR directed against CD19 and incorporating a Toll-like receptor 2 TLR2 co-stimulatory domain interposed between CD28 and CD3ΞΆ signalling domains The trial will screen up to 80 patients in order to enrol and treat approximately 60 participants with WZTL-002 This is a single arm open-label phase 2 trial designed to evaluate the efficacy safety cellular kinetics and pharmacodynamic properties of WZTL-002 for the second- or third-line treatment of rr LBCL
Eligible participants will undergo leukapheresis to harvest peripheral blood mononuclear cells the starting material for the manufacture of the autologous third generation anti-CD19 CAR T-cell product WZTL-002 After WZTL-002 manufacture and confirmation that product release criteria are met participants will receive lymphodepleting chemotherapy comprising fludarabine and cyclophosphamide on days -5 to day -3 inclusive WZTL-002 will be administered intravenously on day 0 as a single dose
After WZTL-002 administration participants will be monitored closely for 14 days including targeted assessments for the specific CAR T-cell related toxicities Cytokine Release Syndrome CRS and Immune Effector Cell Neurotoxicity Syndrome ICANS CRS ICANS and grade 3 or higher neutropenia thrombocytopenia or anemia persisting beyond day 30 will be recorded as adverse events of special interest PETCT scans to assess treatment response will take place at screening pre-lymphodepletion and at 28 days 3 months and 6 months after WZTL-002 infusion and CT scans to assess duration of response at 12 and 24 months after WZTL-002 infusion Samples will be taken to determine WZTL-002 cellular kinetics and the depth and duration of B-cell aplasia pharmacodynamic analysis
Follow-up beyond month 24 will take place within the Center for International Blood and Marrow Transplant Research CIBMT Cellular Therapies Registry or the Australasian Bone Marrow Transplant Recipient Registry ABMTRR and in a subsequent long-term follow-up study
Eligible participants will undergo leukapheresis to harvest peripheral blood mononuclear cells the starting material for the manufacture of the autologous third generation anti-CD19 CAR T-cell product WZTL-002 After WZTL-002 manufacture and confirmation that product release criteria are met participants will receive lymphodepleting chemotherapy comprising fludarabine and cyclophosphamide on days -5 to day -3 inclusive WZTL-002 will be administered intravenously on day 0 as a single dose
After WZTL-002 administration participants will be monitored closely for 14 days including targeted assessments for the specific CAR T-cell related toxicities Cytokine Release Syndrome CRS and Immune Effector Cell Neurotoxicity Syndrome ICANS CRS ICANS and grade 3 or higher neutropenia thrombocytopenia or anemia persisting beyond day 30 will be recorded as adverse events of special interest PETCT scans to assess treatment response will take place at screening pre-lymphodepletion and at 28 days 3 months and 6 months after WZTL-002 infusion and CT scans to assess duration of response at 12 and 24 months after WZTL-002 infusion Samples will be taken to determine WZTL-002 cellular kinetics and the depth and duration of B-cell aplasia pharmacodynamic analysis
Follow-up beyond month 24 will take place within the Center for International Blood and Marrow Transplant Research CIBMT Cellular Therapies Registry or the Australasian Bone Marrow Transplant Recipient Registry ABMTRR and in a subsequent long-term follow-up study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1305-7917 | OTHER | None | None |