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CAR T-cell Therapy

NEXI-001 + Decitabine for AML or MDS

Phase 1

Waitlist Available

Led By Monzr M Al Malki

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) ≤ 1 or Karnofsky performance score (KPS) ≥ 70

At least 100 days post allogeneic HCT

Must not have

The donor has an active bacterial or fungal infection not responding to treatment

Clinically significant uncontrolled illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a new therapy called NEXI-001, which involves modifying a patient's immune cells to attack cancer cells. The trial is specifically for patients with acute

Who is the study for?

This trial is for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has returned after treatment or hasn't responded to previous treatments, and who have had a matched donor stem cell transplant. Specific eligibility details are not provided.

What is being tested?

The trial tests the safety and optimal dose of NEXI-001, a CAR T-cell therapy, combined with decitabine and lymphodepleting chemotherapy using fludarabine and cyclophosphamide in patients with relapsed/refractory AML or MDS post-transplant.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related symptoms, impact on blood cell counts leading to increased infection risk, fatigue, nausea, as well as potential organ damage due to the powerful nature of this combined therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself and carry out daily activities.

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I had a stem cell transplant from a donor over 100 days ago.

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Half of my T-cells match my donor's, confirmed by a PCR test.

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I am 18 years old or older.

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My donor is a perfect match for all 8 HLA markers.

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My cells express HLA-A*0201.

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My lung function tests are above 50% of the expected value or my oxygen levels are above 92% without assistance.

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I haven't had severe side effects from NEXI-001 that lasted more than 3 days.

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My AML/MDS has returned or didn't respond after a stem cell transplant.

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My kidney function is normal, based on recent tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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The donor I have has an ongoing infection that isn't getting better with treatment.

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I do not have any uncontrolled serious illnesses.

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I am currently experiencing active graft-versus-host disease.

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I am on steroids or immunosuppressants as I start LD chemotherapy.

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I have had two previous bone marrow transplants from donors.

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I have had more than 3 treatments for leukemia after my stem cell transplant.

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I am not pregnant or breastfeeding.

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I have a serious heart condition.

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I have not needed drugs to suppress my immune system for an autoimmune disease in the last 2 years.

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I have not had major surgery or serious injury in the last 4 weeks.

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I have a history of seizures or significant neurological conditions.

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I do not have an active infection needing antibiotics when starting LD chemotherapy.

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I have not experienced severe side effects like CRS, ICANS, or HLH/MAS from NEXI-001.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicity

Incidence of adverse events (AEs)

Secondary study objectives

Complete response

Determine the immunophenotype of NEXI-001 T cells

Duration of response

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (NEXI-001, decitabine, chemotherapy)Experimental Treatment12 Interventions

DONOR: Donors undergo leukapheresis on study. PATIENTS: Patients may receive bridging therapy per standard of care ≥ 14 days prior to the start of cycle 1. Patients receive decitabine IV over 1 hour QD on day -3, -5 or -10 to day -1, lymphodepletion chemotherapy with fludarabine IV over 30 minutes QD and cyclophosphamide IV over 60 minutes QD on day -5 to -3 and then receive NEXI-001 IV over 30 minutes QD on days 1, 8 and 15 of cycle 1. Cycles repeat every 33 or 38 days in the absence of disease progression or unacceptable toxicity. If NEXI-001 cells remain and treatment criteria are met, patients may receive and additional cycle of decitabine IV over 1 hour QD on day -5 to -1 and NEXI-001 IV QD on days 1, 8 and 15 in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening, bone marrow aspirate and/or bone marrow biopsy, PET/ CT scan or MRI and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~710

Computed Tomography

2017

Completed Phase 2

~2790