Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04284228
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2020-02-03
Brief Title:
Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT
Sponsor:
NexImmune Inc
Organization:
NexImmune Inc
Study Overview
Official Title:
A Phase 1 2 Study to Evaluate the Safety Tolerability and Initial Anti-Tumor Activity of Adoptively Transferred T Lymphocytes Targeting WT1 PRAME and Cyclin A1 AML or MDS Patients With Relapsed Disease After Matched Allogeneic HCT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This Research study is being done to characterize the safety tolerability and preliminary antitumor activity of the NEXI-001 T cell product a new experimental therapy which contains populations of CD8 T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS who have relapsed disease after an allogeneic hematopoietic cell transplant HCT
The study will enroll AML or MDS patients who have either Minimal Residual Disease MRD or relapsed disease after a human leukocyte antigen HLA-matched allogeneic HCT Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study Eligible patients for this study must also have 50 T-cell chimerism from the original donor at the time study entry
The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured Choice of bridging therapy administered will be per the Investigators discretion but is limited to acceptable agents as specified in the protocol Bridging therapy will be administered prior to lymphodepleting LD therapy with the last dose of the bridging therapy administered 14 days prior to initiation of LD therapy Within 72 hours after completing LD therapy patients will receive a single IV infusion of the NEXI-001 T cell product
The study will enroll AML or MDS patients who have either Minimal Residual Disease MRD or relapsed disease after a human leukocyte antigen HLA-matched allogeneic HCT Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study Eligible patients for this study must also have 50 T-cell chimerism from the original donor at the time study entry
The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured Choice of bridging therapy administered will be per the Investigators discretion but is limited to acceptable agents as specified in the protocol Bridging therapy will be administered prior to lymphodepleting LD therapy with the last dose of the bridging therapy administered 14 days prior to initiation of LD therapy Within 72 hours after completing LD therapy patients will receive a single IV infusion of the NEXI-001 T cell product
Detailed Description:
The NEXI-001 is an adoptive cellular therapy product which contains populations of antigen-specific CD8 T cells The antigen-specific CD8 T cells in the NEXI-001 T cell product are derived from Peripheral Blood Mononuclear Cells PBMC obtained from the original stem cell donor During the manufacturing process these cells are primed and expanded ex vivo using nano-size artificial Antigen Presenting Cells aAPC loaded with five leukemia associated antigen peptides in combination with a proprietary T cell enrichment and expansion process
The NEXI-001 T cell product is restricted to patients that are HLA-A201 allele positive for this study
There are two parts to this study a Safety Evaluation Phase and a Dose Expansion Phase The Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cell product and will consist of Dose Escalation at two dose levels - each with cohorts of three patients
When all three patients at Dose Level 1 have dosed and cleared the DLT period three additional patients will be enrolled at Dose Level 2 When three patients have cleared the DLT period at the highest dose level that dose will be advanced to the Dose Expansion Phase The Dose Expansion Phase will enroll up to 16 additional patients to further define the safety and evaluate the initial anti-tumor efficacy of the NEXI- 001 T cell product at the dose established from the Safety Evaluation Phase
All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 001 T cell product During this phase all patients will be monitored for AEs and followed for anti-leukemia response until the end of study visit is complete up to one year
Additional assessments for safety disease status and other secondary and exploratory endpoints will also be monitored during the follow-up period
All patients will be followed for overall survival OS from time of disease progression until the last visit of the last patient During this time patients will be followed via telephone or other electronic contact at 12 week intervals for monitoring of OS
The NEXI-001 T cell product is restricted to patients that are HLA-A201 allele positive for this study
There are two parts to this study a Safety Evaluation Phase and a Dose Expansion Phase The Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cell product and will consist of Dose Escalation at two dose levels - each with cohorts of three patients
When all three patients at Dose Level 1 have dosed and cleared the DLT period three additional patients will be enrolled at Dose Level 2 When three patients have cleared the DLT period at the highest dose level that dose will be advanced to the Dose Expansion Phase The Dose Expansion Phase will enroll up to 16 additional patients to further define the safety and evaluate the initial anti-tumor efficacy of the NEXI- 001 T cell product at the dose established from the Safety Evaluation Phase
All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 001 T cell product During this phase all patients will be monitored for AEs and followed for anti-leukemia response until the end of study visit is complete up to one year
Additional assessments for safety disease status and other secondary and exploratory endpoints will also be monitored during the follow-up period
All patients will be followed for overall survival OS from time of disease progression until the last visit of the last patient During this time patients will be followed via telephone or other electronic contact at 12 week intervals for monitoring of OS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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