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NK Cell Therapy

DVX201 for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Thomas W LeBlanc, MD
Research Sponsored by Deverra Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a diagnosis of persistence or relapse/progression of AML with ≥ 5% blasts in the marrow or blood following at least 1 cycle of induction therapy, or a diagnosis of intermediate, high, or very high-risk MDS resistant or refractory to at least one course of therapy including demethylating agents with ≥ 5% blasts in the marrow or blood, or a diagnosis of overlap of an MPN with MDS features resistant or refractory to at least one course of therapy including demethylating agents with ≥ 5% blasts in the marrow or blood
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months start of therapy
Awards & highlights

Study Summary

This trial is testing an investigational cell therapy, DVX201, to see if it can help patients with leukemia or myelodysplastic syndrome.

Who is the study for?
Adults over 18, weighing at least 40 kg with relapsed/refractory AML or high-risk MDS who have tried other treatments without success. They must be in good physical condition (ECOG status of 0 or 1), have adequate liver and kidney function, not be pregnant/breastfeeding, and agree to use contraception. Those with mild autoimmune disorders may qualify but can't join if they've had recent major treatments, active severe GvHD, ongoing infections, another cancer within the last three years (with some exceptions), a history of seizures or CNS-involved autoimmune diseases.Check my eligibility
What is being tested?
DVX201 is being tested; it's an investigational NK cell therapy designed to boost the immune system by infusing healthy NK cells that can fight cancer cells remaining after chemotherapy. The trial aims to determine its safety and effectiveness for patients with certain types of blood cancers who haven't responded well to previous therapies.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but could include reactions related to immune activation such as fever or fatigue, infusion-related reactions like allergic responses, and possibly worsening of underlying conditions due to immune system stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My AML or MDS has not improved or has worsened after treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am not pregnant or breastfeeding and won't be for 3 months after the last treatment.
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I had a bone marrow transplant or donor lymphocyte infusion over 60 days ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months start of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months start of therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities
Secondary outcome measures
Disease response
Duration of response
Other outcome measures
1. Evaluation of NK cells in blood samples after DVX201 infusion to look for markers of NK cell exhaustion and activation
Length of time that DVX201 (NK cells) remain in the blood

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
Lymphodepleting (LD) chemotherapy will be administered daily for 3 days to all subjects prior to DVX201. Lymphodepleting chemotherapy will consist of the following: Cyclophosphamide 300 mg/m2 IV over 30 to 60 minutes daily x 3 (day -5 to day - 3) Fludarabine 30 mg/m2 IV over 30 minutes daily x 3 (day -5 to day -3) Patients will receive DVX201 at one of 3 prespecified doses infused on day 0 and 7 (± 1 day) for 1 cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DVX201
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Duke UniversityOTHER
2,356 Previous Clinical Trials
3,409,083 Total Patients Enrolled
Deverra Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
David A Rizzieri, MDStudy ChairNovant Health
8 Previous Clinical Trials
216 Total Patients Enrolled

Frequently Asked Questions

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

Is this investigation still taking on participants?

"Affirmative. Clinicaltrials.gov states that this research trial, which commenced on December 15th 2021, is actively searching for participants to fill the 18 slots available at 1 medical facility."

Answered by AI

How many participants can take part in this research study?

"Affirmative, clinicaltrials.gov provides evidence that this trial is still recruiting participants. It was initially posted on December 15th 2021 and has been revised most recently as of February 11th 2022. The study requires 18 test subjects across 1 site to complete their research project."

Answered by AI

Has the FDA granted authorization to DVX201?

"As DVX201 is in its initial phase of clinical trials, our team at Power has only allocated a score of 1 to the drug's safety profile due to limited evidence supporting efficacy and safety."

Answered by AI
~1 spots leftby Jun 2024