CNDO-109-AANK for AML in First Complete Remission (CR1)

NCT01520558 | Unknown Phase 1 Results

• 1 other identifier: CNDO109-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, open-label, non-controlled, non-randomized dose-escalating Phase 1 clinical study designed to examine the safety of infusing escalating doses of CNDO-109-Activated Allogeneic Natural Killer Cells-(from a first or second degree relative), after a preparatory chemotherapy regimen, in adult patients with acute myeloid leukemia (AML) who are in their first complete remission at the time of enrollment, are not candidates for stem cell transplant, and are considered to be at high risk for recurrence.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; High Risk Relapse; Complete Remission; Allogeneic Natural Killer Cells

Outcome Measures

Primary Outcomes (1)

• Define MTD

  The primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence. The MTD outcome measure is presented as number of participants with DLTs.

  up to 30 days post dose

Secondary Outcomes (2)

• Additional Safety Profile Beyond MTD

  up to 360 days post dose

• Efficacy

  from the date of documented CR until the first documented progression date or until day 360 post dose whichever is sooner

Study Arms (3)

CNDO-109-AANK Cells Dose 1

EXPERIMENTAL

In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10\^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.

Biological: CNDO-109-AANK Cells

CNDO-109-AANK Cells Dose 2

EXPERIMENTAL

In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.

Biological: CNDO-109-AANK Cells

CNDO-109-AANK Cells Dose 3

EXPERIMENTAL

In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.

Biological: CNDO-109-AANK Cells

Interventions

CNDO-109-AANK Cells BIOLOGICAL

Single dose, infusion

Also known as: CNDO-109-Activated Allogeneic Natural Killer Cells

CNDO-109-AANK Cells Dose 1; CNDO-109-AANK Cells Dose 2; CNDO-109-AANK Cells Dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has pathologically documented AML and is in CR1 at the time of the screening visit
• The patient achieved CR1 within 10 weeks of the screening visit; the patient may have received post-remission consolidation therapy (except for transplant) prior to the screening visit
• A bone marrow aspiration performed within 21 days prior to the start of pre-infusion preparative therapy confirms the patient is in CR1
• The patient has either refused or is not considered an appropriate immediate candidate for transplantation and is considered to be at high risk for recurrence by having at least one of the following prognostic factors:
• High risk cytogenetics (-5, -7, del(5q), abnormal 3q, 11q23 translocations, complex cytogenetics) or if cytogenetics are normal the presence of a FLT3 mutation without a NPM1 mutation
• Age \> 60 years
• Antecedent hematological disorder (AHD)
• AML that is considered to be therapy-related
• FAB subtype M0 (minimally differentiated acute myeloblastic leukemia), M6 (acute erythroid leukemias, including erythroleukemia (M6a) and pure erythroid leukemia (M6b)), or M7 (acute megakaryoblastic leukemia)
• The patient is male or female, age 18 years or older
• The patient has an ECOG performance status of 0, 1, or 2
• The patient has an available NK cell donor who is a HLA haploidentical first-degree (parent, child, or sibling) or second-degree (child of a sibling) relative; minimum testing will be for HLA-A, HLA-B, and HLA-DR with donors matched for 3/6, 4/6 or 5/6 antigens
• The patient has an absence of coexisting medical problems that would significantly increase the risk of the chemotherapy procedure (e.g. poor left ventricular ejection fraction \[LVEF\<40%\])
• The patient has recovered from reversible toxicity from prior therapy. Permanent and stable side effects or changes are acceptable if ≤ Grade 1 (CTCAE, v4.03)
• The patient has serum creatinine \<2×ULN and not rising for at least 2-4 weeks before chemotherapy. If elevated, the 24-hour creatinine clearance must be \>50 mL/min

You may not qualify if:

• The patient had a previous bone marrow or stem cell transplant
• The patient is seropositive for HIV 1, HIV 2, HBV, or HCV
• The patient has a psychiatric, addictive, neurological or other disorder that compromises the ability to give informed consent or comply with study requirements
• The patient is pregnant (confirmed by urine or serum pregnancy test) or lactating
• The patient has a recently diagnosed active malignancy requiring therapy
• The patient has an uncontrolled infection, or is receiving anti-fungal treatment for an ongoing infection
• The patient has known hypersensitivity to bovine proteins
• The patient has any condition that will place the patient at undue risk or discomfort as a result of adherence to study procedures
• The patient requires treatment with corticosteroids at a dose \> 0.1 mg/kg/day or has a known allergy to DSMO

Sponsors & Collaborators

• Coronado Biosciences, Inc.: lead

Study Sites (4)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

University of Minnesota - Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: Coronado Biosciences

nsilver@coronadobio.com

7816524516

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 30, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: February 1, 2018
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-04

Locations

US (4)