Safety Study of Chimeric Antigen Receptor Modified T-cells Targeting NKG2D-Ligands

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Multiple Myeloma

In brief

This Phase I clinical trial is evaluating chimeric-antigen receptor (CAR) T-cells (CM-CS1 T cells) which recognize NKG2D-ligands on the surface of cancer cells. This study evaluates the safety and feasibility of administering a single intravenous dose of CM-CS1 CAR T-cells to patients with AML, MDS-RAEB and Multiple Myeloma.

Key facts

Study ID

NCT02203825

Run by

Celyad Oncology SA

People needed

12

Starts

2015-03-01

Expected to finish

2018-03-01

Last updated by the study team

2018-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participants who have received chemotherapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
• Concurrent systemic steroid or other immunosuppressive therapy.
• Participants who are concurrently receiving any other investigational agents, or have received another investigational agent within 3 weeks before enrollment.
• Participants who have received prior allogeneic stem cell transplantation, gene therapy, or adoptive T-cell therapy.
• Active infections necessitating use of treatment antibiotics/antivirals during the screening period (prophylaxis is acceptable) or evidence of an active communicable infectious disease.
• Participants who underwent major surgery within 4 weeks before day 0 of planned CM-CS1 T-cell infusion (this does not include placement of vascular access device or tumor biopsies).
• Participants with any known history of primary immunodeficiency.
• History of allergic reactions or hypersensitivity attributed to Human serum albumin or Plasma-lyte A.
• Uncontrolled intercurrent illness or serious uncontrolled medical disorder
• Pregnancy or breastfeeding
• Known HIV-positive participants are ineligible because the effect of transducing HIV-infected lymphocytes with the chimeric NKG2D- transgene on the disease course is unknown.
• Clinically relevant active infection including active hepatitis B or C or any other concurrent disease which in the judgment of the Investigator would make the subject inappropriate for enrollment on this study.
• Active autoimmune disease
• History of a malignancy other than one of the malignancies in this study with exception of the following circumstances:
• Patients with a history of malignancy who have been adequately treated and have been disease-free for at least 2 years are not excluded.
• Patients with adequately treated active non-invasive cancers (such as non-melanomatous skin cancer or in-situ bladder, cervical and breast cancers) are not excluded.
• Unwillingness to use an effective contraceptive method during the study and at least 4 months after administration of CM-CS1 T-cells unless subject is naturally infertile.

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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