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CAR T-cell Therapy

T Cell Therapy for AML or MDS

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at year1

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met