T Cell Therapy for AML or MDS

Recruiting at 4 trial locations

Overseen By Gloria Hoyah

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NexImmune Inc.

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: GvHD, Cardiovascular disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

22 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Investigator's 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.

Research Team

Juan Varela, MD, PhD

Principal Investigator

Principal Investigator

Eligibility Criteria

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.

Inclusion Criteria

My tests show mutations in my blood cell genes.

You understand and agree to take part in the study, and you are able to follow the study's requirements and provide any needed samples for research.

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bridging Therapy

Participants undergo bridging therapy for disease control while the NEXI-001 T cell product is being manufactured

Varies

Lymphodepleting Therapy

Participants receive lymphodepleting therapy prior to the infusion of NEXI-001 T cell product

2 weeks

Treatment

Participants receive a single IV infusion of the NEXI-001 T cell product

1 day

Post-Treatment Follow-Up

Participants are monitored for adverse events and anti-leukemia response until the end of study visit is complete

Up to 1 year

Overall Survival Follow-Up

Participants are followed for overall survival from time of disease progression until the last visit of the last patient

12 week intervals

Treatment Details

Interventions

• NEXI-001 T cell product

Trial Overview 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.

Participant Groups

Group I: Safety Evaluation Phase Experimental Treatment 1 Intervention

Treatment with NEXI-001 T cells, derived from PBMCs of original HLA- matched HCT donor.

Group II: Dose Expansion Phase Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

NexImmune Inc.

Lead Sponsor

Trials

3

Recruited

70+