An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)

March 23, 2023 updated by: EQRx International, Inc.
This program is intended to provide access to sugemalimab for participants with R/R ENKTL, after their disease failed to respond to prior treatment regimen(s), preceding marketing authorization by the local regulatory agency.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants are eligible to receive sugemalimab as part of this EAP only if all the following criteria apply:

  1. Participants must be 18 to 99 years of age inclusive, at the time of signing the informed consent.
  2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  3. Participants who have a histologically confirmed ENKTL. Both nasal and non-nasal ENKTL are allowed.
  4. Participants must have R/R ENKTL that has progressed on or after asparaginase-based chemotherapy or chemoradiotherapy. (Relapse: disease progression after response to the last treatment; refractory: no response to the last treatment).
  5. Women of childbearing potential (WOCBP), as defined in Section 13.3 must have a negative serum pregnancy test ≤7 days before the first dose of sugemalimab. WOCBP or fertile men and their WOCBP partners must agree to use an effective contraceptive method from providing signed ICF through 6 months after the last dose of the sugemalimab.
  6. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

Participants are not eligible to participate in the Sugemalimab ENKTL EAP if any of the following criteria apply:

  1. Participants with aggressive natural killer cell leukemia or ENKTL participants who have any degree of leukemic involvement.
  2. Participants with hemophagocytic lymphohistiocytosis.
  3. Subjects requiring systemic corticosteroid or any other immunosuppressive therapy. (Subjects are permitted to use topical, ocular, intra-articular, intranasal and inhaled corticosteroids [with minimal systemic absorption]; a short course [≤ 7 days] of corticosteroids for prophylaxis [e.g., hypersensitivity to contrast media] or for treatment of non-autoimmune conditions [e.g., delayed hypersensitivity caused by contacting allergens])
  4. Participants with underlying condition that in the treating physician's opinion would increase the risk of AEs related to sugemalimab administration or confound the assessment for its toxicity. Participants who have had prior chemotherapy, immunotherapy, biological therapy (including cancer vaccine, cytokine therapy or growth factors to treat cancer) used as a systemic treatment for cancer will require 28 days of washout period.
  5. Participants with active, known or suspected autoimmune disease.
  6. Any liver function panel analyte (LFT) value > 2.5 × upper limits of normal reference range (ULN) which includes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and gamma-glutamyl transferase (GGT) at baseline. Bilirubin > 1.5 × ULN.
  7. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
  8. Participants in the treating physician's opinion are not suitable for participating in this EAP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EQRx International, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 11, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EQ165-501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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