AzTrials
AzTrials

AML, Adult RecurrentPhase 1NCT04901416

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

A Phase 1 study testing DVX201 in people with AML, Adult Recurrent and MDS, run by Coeptis Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study involves the use of an investigational cell therapy known as DVX201. DVX201 is an investigational cell therapy that contains a type of white blood cell called natural killer (NK) cells. NK cells are a normal part of your immune system and have a lifespan of only about two weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML, Adult Recurrent, MDS
What is being tested?
DVX201
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
15 Dec 2021to 4 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥ 18 years of age and weighing at least 40 kg, inclusive, with persistence or relapse/progression of AML, MDS, or MDS/MPN overlap (within 28 days of enrollment) and:
  • a diagnosis of persistence or relapse/progression of AML and ≥ 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 according to IPSS-R classification (Greenberg et al., 2012) who are resistant or refractory to at least one course of therapy including demethylating agents (having had at least 4 cycles) with ≥ 5% blasts in the marrow or blood, or
  • a diagnosis of overlap of an MPN with MDS features and also are resistant or refractory to at least one course of therapy including demethylating agents (having had at least 4 cycles) with ≥ 5% blasts in the marrow or blood.
  • Written informed consent in accordance with federal, local, and institutional guidelines.
  • Must be able to adhere to the study visit schedule and other protocol requirements.
Show all 15Show fewer
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Meet the following laboratory criteria within 7 days of enrollment:
  • ALT/SGPT and AST/SGOT < 3x the upper limit of normal (ULN) unless due to underlying disease state
  • Calculated creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft Gault and dialysis independent (Cockcroft et al., 1976)
  • Total bilirubin ≤ 2.0 mg/dL (Patients with Gilbert's or Meulengracht Syndrome must have a total bilirubin < 5.0 mg/dL).
  • Females cannot be pregnant or breast-feeding from time of enrollment or for 3 months post final infusion.
  • Women of childbearing potential is willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of protocol-specified therapy. Men who have a female partner of childbearing potential are together willing to use 2 highly effective forms of contraception for at least an additional 3 months after the last dose of protocol- specified therapy.
  • Patients status post allogeneic BMT or other donor lymphocyte infusions are eligible, but they must be at least 60 days from the last infusion of cell therapy products.
  • Patients must have other anti-leukemia therapies stopped 2 weeks prior to infusion on this study. Hydroxyurea and/or pheresis ARE allowed prior to this study until 1 day prior to infusion.

Who cannot join

  • Weight less than 40 kg.
  • Patients with progressive infections at time of first infusion (patients with treated infections documented as controlled by the treating team are eligible).
  • Patients with history of active seizure disorder (having a documented seizure within the prior year) or any autoimmune disease with CNS involvement.
  • Major surgery, chemotherapy, systemic therapy (excluding hydroxyurea, steroids, and any targeted small molecules or biologics), or radiotherapy within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1.
  • Patients with proven, progressive severe autoimmune disease such as multiple sclerosis, active Guillain Barré syndrome, poliomyelitis, Sjogren's are not eligible.
  • Given the immediate, life threatening nature of the relapsed cancer in this patient population, those with other stable and non-immediate non-threatening autoimmune disorders (such as thyroid disease or diabetes and others) are eligible.
Show all 13Show fewer
  • Diagnosis of any other malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention other than hormonal therapy, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
  • Any active acute Graft-versus-Host Disease (GvHD) > Grade 1 overall or systemic treatment of more than 10 mg prednisone daily (or equivalent); patients must have been off any calcineurin inhibitors for at least 28 days prior to starting therapy on this study.
  • Current use of immunosuppressive medications at the time of study enrollment and within 2 weeks of any study treatments, except:
  • Intranasal, inhaled, topical steroids, or local steroid injection
  • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
  • Steroids as premedication for hypersensitivity reactions at physiologic doses ≤ 10 mg/day of prednisone or equivalent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Hospital

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: An Open-Label Pilot Study to Evaluate the Safety and Efficacy of DVX201 NK Cells in Patients With Relapsed or Refractory AML or High Risk MDS or High Risk Overlapping Myelodysplastic / Myeloproliferative Neoplasms

This study involves the use of an investigational cell therapy known as DVX201. DVX201 is an investigational cell therapy that contains a type of white blood cell called natural killer (NK) cells. NK cells are a normal part of your immune system and have a lifespan of only about two weeks. They are called natural killer cells because they have the natural ability to identify and kill cells in the body that are abnormal, like cancer cells or virally infected cells. But fighting cancer can also lead to exhaustion and abnormal function of NK cells. It can also result in a significant decrease in the number of NK cells in the blood, making it more difficult for the immune system to control the disease. We believe that infusion of healthy, functional NK cells into patients with AML or MDS may boost the immune system and help by killing cancer cells that remain after chemotherapy. DVX201 is an investigational NK cell therapy that may provide a rapid and temporary source of healthy NK cells that are better able to fight those cancer cells.

Being tested
DVX201
Keywords
NK cells, AML, Allogeneic, MDS, Relapse
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DVX201Biological

    Based upon the occurrence of DLT (does limiting toxicity), the MTD will be estimated as the highest dose at which the toxicity probability is the closest to the target probability (denoted pT=0.30) following up to 2 doses of DVX201. The corresponding dose allocation methodology is a modified toxicity interval design based upon (Ji et al., 2010; Ji et al., 2013).

    All patients who have at least one dose initiated will be included in the safety analysis. Patients who are enrolled but never exposed to investigational product will be replaced for all analyses. Patients who get exposed to lymphodepleting chemotherapy will be followed and reported for outcomes overall, but for determination of safety and efficacy, only those subjects who have been exposed to the investigational agent will be included.

Study groups in NCT04901416
Study groupRoleWhat they receive
Experimental ArmExperimental1. Lymphodepleting (LD) chemotherapy will be administered daily for 3 days to all subjects prior to DVX201. Lymphodepleting chemotherapy will consist of the following: 1. Cyclophosphamide 300 mg/m2 IV over 30 to 60 minutes daily x 3 (day -5 to day - 3) 2. Fludarabine 30 mg/m2 IV over 30 minutes daily x 3 (day -5 to day -3) 2. Patients will receive DVX201 at one of 3 prespecified doses infused on day 0 and 7 (± 1 day) for 1 cycle.
Receives: Biological: DVX201

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities

    Dose limiting toxicities include toxicities with cell therapy infusion, CRS, organ toxicity, GVHD as defined in the protocol

    Measured: Through 28 days post second infusion of ccell therapy (DVX201)

Secondary outcomes (2)

  1. Disease response

    Patient's response to DVX201 as CR, CRi, PR, MLFS, PD, or NR based on the Investigator's evaluation using standardized NCCN criteria

    Measured: through approximately 30 days post second cell therapy infusion (DVX201)

  2. Duration of response

    Patients with disease response will be followed to see how long the duration of this response is and if primary disease recurs or worsens

    Measured: Through study completion, an average of 6 months start of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start15 Dec 2021
  3. Primary completion15 Oct 2023
  4. Study completion4 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single arm, unblinded, non-randomized Phase 1 dose-finding study of DVX201.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04901416
Sponsor's protocol ID
DVX201-AML-01
Status last verified
Apr 2024
First submitted
21 May 2021
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DVX201 in people with AML, Adult Recurrent and MDS, run by Coeptis Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (time frame: Through 28 days post second infusion of ccell therapy (DVX201)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04901416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in