Deverra: Phase 1:DVX201 (Blood Cancers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental cell therapy called DVX201 (study drug) is a safe and effective treatment for people with AML, High Risk MDS, or MPN.

What is the Condition Being Studied?

Relapsed or Refractory Acute Myeloid Leukemia (AML), High Risk Myelodysplastic Syndrome (MDS), or Myeloproliferative Neoplasms (MPN)

Who Can Participate in the Study?

Adults diagnosed with AML, High Risk MDS, or Myeloproliferative Neoplasms who:

- Have relapsed/progression of AML and at least 5% blasts in the marrow or blood; OR

- Have resistant or refractory intermediate, high or very high risk MDS with at least 5% blasts in the marrow or blood; OR

- Have resistant or refractory MPN with MDS features with at least 5% blasts in the marrow or blood; OR

- Do not have an uncontrolled infection

- Do not weigh less than 40 kg

For more information about who can join this study, please contact the study team at 919-660-2077.

Age Group
Adults

What is Involved?

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:

- Have a physical exam

- Have blood drawn

After the screening period, you will receive 3 consecutive days of chemotherapy intravenously (IV) to lower your number of white blood cells. We will give you the chemotherapy drugs cyclophosphamide and fludarabine. These two drugs are approved, but their use in combination with the study drug is considered investigational.

You will receive the study drug through IV. The infusion lasts about 10-15 minutes and will be 3 days after you finish the chemotherapy. If you tolerate the dose of study drug, you will receive one more dose about 7 days later.

Once you complete the study regimen you will enter a follow up period. The study team will call you approximately every 12 weeks for up to 6 months to see how you are feeling.

Study Details

Full Title
An Open-Label Pilot Multicenter Study to Evaluate the Safety and Efficacy of DVX201 NK Cells in Patients with Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome or High Risk Overlapping Myelodysplastic / Myeloproliferative Neoplasms
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00109079
NCT: NCT04901416
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment