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NK Cell Therapy

DVX201 for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By David Rizzieri, MD

Research Sponsored by Coeptis Therapeutics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months start of therapy

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Coeptis TherapeuticsLead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Duke UniversityOTHER

2,375 Previous Clinical Trials

3,426,905 Total Patients Enrolled

Deverra Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

12 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

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS

2021. "Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04901416.