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CAR T-cell Therapy

Infusion of NEXI-001 T Cells for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Led By Juan Varela, MD, PhD
Research Sponsored by NexImmune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Detection of known or new myeloid gene mutations
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at year1
Awards & highlights

Study Summary

This trial is being done to study a new experimental therapy, NEXI-001, which is a T cell product targeting multiple leukemia associated antigen peptides, in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome who have relapsed disease after an allogeneic hematopoietic cell transplant.

Who is the study for?
This trial is for adults over 18 with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed after a matching bone marrow transplant. They must be in good physical condition, able to follow the study plan, and have specific genetic markers. Those with mismatched transplants or certain levels of disease are not eligible.Check my eligibility
What is being tested?
The trial tests NEXI-001 T cells, an experimental therapy targeting leukemia antigens in AML/MDS patients post-transplant relapse. It involves bridging therapy for disease control while preparing the T cell product, followed by lymphodepleting therapy and then a single infusion of NEXI-001.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to infused T cells, symptoms from bridging and lymphodepleting therapies such as fatigue, nausea, infection risk increase; exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tests show mutations in my blood cell genes.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have AML or MDS and show signs of relapse or minimal residual disease after a stem cell transplant.
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My genetic test shows I have the HLA-A*0201 gene.
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I am 18 years old or older.
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My donor is a perfect match for me based on 10 specific genetic markers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at year1
This trial's timeline: 3 weeks for screening, Varies for treatment, and at year1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events of Special Interest (AESIs) events
Adverse Events of Special Interest (AESIs) events (AEs)
Adverse Events of Special Interest (AESIs) events (AEs) Reporting
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety Evaluation PhaseExperimental Treatment1 Intervention
Treatment with NEXI-001 T cells, derived from PBMCs of original HLA- matched HCT donor.
Group II: Dose Expansion PhaseExperimental Treatment1 Intervention
Dose Expansion Phase to further define the safety, tolerability and initial anti-tumor efficacy of the NEXI-001 T cell product at the dose established from the Safety Evaluation Phase.

Find a Location

Who is running the clinical trial?

NexImmune Inc.Lead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
Juan Varela, MD, PhDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
9 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this research?

"In order to move forward, this trial requires 22 willing and eligible participants. The specified inclusion criteria must be met by potential patients who can inquire about the trial at locations like Advent Health Medical Group Blood & Marrow Transplant in Orlando, Florida or City of Hope Comprehensive Cancer Center in Duarte, California."

Answered by AI

In how many different medical clinics is this medical study being run today?

"This clinical trial is presently being conducted at 5 sites. The locations are based in Orlando, Duarte and New york along with other locations. To minimize travel requirements, participants should select the clinic closest to them."

Answered by AI

Are patients currently being enrolled in this research?

"That is correct. The clinicaltrials.gov website has the most recent update which was on February 16th, 2021 and it states that the study is still looking for 22 individuals who meet the requirements. There are 5 locations where you could potentially participate in this trial."

Answered by AI
~2 spots leftby Oct 2024