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Multiple MyelomaPhase 1NCT02955550

A Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion With or Without Subcutaneous Recombinant Human Interleukin-2 (rhIL-2) Following Autologous Stem Cell Transplant for Multiple Myeloma (MM)

A Phase 1 study testing rhIL-2 and PNK-007 in people with Multiple Myeloma, run by Celularity Incorporated at 7 sites in United States.

Completed

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

Official record
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Trial summary

This study will find the highest acceptable treatment dose and timing of infusion of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with multiple myeloma. The NK cells will be given at varying days post autologous stem cell transplant. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
rhIL-2 and PNK-007
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
7 sitesUnited States
Study dates
5 Jan 2017to 4 Jun 2019
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Subject has eligible disease status:
  • Newly diagnosed and are undergoing induction therapy prior to undergoing first Autologous stem cell transplant (ASCT) or
  • Myeloma patients with prior relapse undergoing first ASCT. or
  • Myeloma patients with relapsed disease after first ASCT who are undergoing second ASCT. Subjects must have achieved at least a partial response (PR) prior to proceeding to ASCT.
  • Subject is > 18 and ≤ 70 years of age at the time of signing the informed consent form (ICF).
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  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study schedule and other protocol requirements.
  • Performance status of Karnofsky performance status ≥ 70% or Eastern Cooperative Oncology Group (ECOG) < 2
  • Ability to be off immunosuppressive drugs for at least 3 days prior to the PNK-007 cell infusion. Steroids at the equivalent of no more than 5 mg prednisone per day are permissible.
  • Be a candidate for ASCT based on institutional practices.
  • Subjects must have autologous peripheral blood stem cell graft available in storage for additional transplant in the event of engraftment failure.
  • Female of childbearing potential (FCBP) must:
  • Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinence* from heterosexual contact.
  • Either commit to true abstinence* from heterosexual contact (which must be reviewed at applicable study visits and source documented) or agree to use, and be able to comply with, effective contraception without interruption, during the study therapy (including dose interruptions), and for 28 days after discontinuation of PNK-007.
  • A female of childbearing potential (FCBP) is a female who:
  • 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
  • Male subjects must:
  • Practice true abstinence* (which must be reviewed at applicable study visits) or agree to use a condom during sexual contact while participating in the study, during dose interruptions and for at least 28 days following PNK-007 discontinuation, even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception]).

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • Subject has plasma cell leukemia.
  • Subject has non-secretory myeloma.
  • Subject has previously undergone allogeneic stem cell transplant.
  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Subject has any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he or she were to participate in the study.
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  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject has a body weight exceeding 120 kg.
  • Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase ≥ 2.5 x the upper limit of normal (ULN) at screening.
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening calculated using the Modification of Diet in Renal Disease Study equation.
  • Subject has a bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease) at screening.
  • Subject has had prior treatment with biologic antineoplastic agents no less than 7 days before PNK-007 infusion and at least 5 half-lives. For agents that have known AEs occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur.
  • Subject is pregnant or breastfeeding.
  • Subject has new or progressive pulmonary infiltrates or pleural effusion large enough to be detected by chest x-ray or computed tomography (CT) scan.
  • Subject has active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy.
  • Subject has human immunodeficiency virus (HIV) are excluded due to increased risk of lethal infections when treated with myeloablative chemotherapy.
  • Subject has history of malignancy, other than multiple myeloma (MM), unless the subject has been free of disease for > 3 years from the date of signing the ICF. Exceptions include the following:
  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
  • Subject has a history of severe asthma and is presently on chronic medications or has a history of other symptomatic pulmonary disease.
  • Untreated chronic infection or treatment of any infection with systemic antibiotics within 2 weeks prior to melphalan.
  • Subject has any other organ dysfunction that will interfere with the administration of the therapy according to this protocol.
  • Subject has a resting left ventricular ejection fraction (LVEF) of < 35% obtained by echocardiography or multigated acquisition scan (MUGA).
  • Subject was treated with an investigational product no less than 28 days before PNK-007 infusion. Subject must no longer be a participant in the previous interventional study at the time of the PNK-007 infusion.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mt. Sinai School of Medicine

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Washington Univ School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1, Multicenter, Open-label, Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion Following Autologous Stem Cell Transplant for Multiple Myeloma

This study will find the highest acceptable treatment dose and timing of infusion of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with multiple myeloma.

The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is administered after treatment to help the NK cells expand in the body. The safety of this treatment will be studied and researchers want to learn if NK cells will help in treating multiple myeloma.

Read the detailed description

The primary objective of the study is to assess safety and determine the maximum tolerated dose of PNK-007 as well as the feasibility of treating at various timepoints following ASCT in subjects with multiple myeloma. The secondary objective is to explore the potential clinical efficacy by day 90-100 post ASCT.

Treatment plan includes ASCT followed by PNK-007 which will be administered IV Day 14 post ASCT to determine the maximum tolerated dose. Once the IV Day 14 post ASCT. PNK-007 will be followed by up to six rhIL-2 injections to support the NK cells expansion in the body.

Subjects will be followed for up to 12 months post PNK-007.

Being tested
rhIL-2, PNK-007
Keywords
Multiple Myeloma, Plasma Cell Myeloma, Plasma Cell Neoplasm, Relapsed/refractory Myeloma, PNK-007, Recombinant Human IL-2 (RHIL-2), Human IL-2, Bone Marrow Transplant
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

  • rhIL-2Drug

    Human recombinant Interleukin-2

  • PNK-007Biological

    PNK-007 is a culture-expanded cell population derived from human cord blood hematopoietic stem/progenitor cells.

Study groups in NCT02955550
Study groupRoleWhat they receive
PNK-007 and rhIL-2ExperimentalMelphalan per institutional practices (within Day -5 to 01), ASCT (Day 0), PNK-007 at varying dose levels (within Day 7 to Day 14) and rhIL-2 every other day starting day of PNK-007 administration.
Receives: Drug: rhIL-2; Biological: PNK-007

What is being measured

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

  1. Dose-Limiting Toxicity (DLT)

    Number and severity of adverse events within 28 days of administration

    Measured: Up to 28 days

  2. Maximum Tolerated Dose (MTD)

    The maximum dose safely administered for the treatment of patients with multiple myeloma

    Measured: Up to 28 days

  3. Dose Timing After Autologous Stem Cell Transplant

    The optimal dose timing safely administered for the treatment of patients with multiple myeloma post ASCT

    Measured: Up to 28 days

  4. Adverse Events (AEs)

    Number and severity of adverse events within 12 months of administration

    Measured: Up to 12 months

Secondary outcomes (1)

  1. Response Rate

    Clinical efficacy at day 90-100 post ASCT per International Myeloma Working Group criteria, including minimal residual disease

    Measured: Up to day 100

Timeline

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

  1. First posted4 Nov 2016 (estimated)
  2. Study start5 Jan 2017
  3. Primary completion10 Jul 2018
  4. Study completion4 Jun 2019

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
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955550
Sponsor's protocol ID
CCT-PNK-007-MM-001
Status last verified
Jul 2020
First submitted
2 Nov 2016
Last updated
22 Jul 2020
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 rhIL-2 and PNK-007 in people with Multiple Myeloma, run by Celularity Incorporated at 7 sites 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 19 inclusion and 27 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Dose-Limiting Toxicity (DLT) (time frame: Up to 28 days). The study lists 4 primary outcomes in all. 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 NCT02955550.

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 22 Jul 2020.

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