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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05131438
Expanded Access Status : No longer available
First Posted : November 23, 2021
Last Update Posted : March 27, 2023
Sponsor:
Information provided by (Responsible Party):
EQRx International, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Extranodal NK/T-cell Lymphoma Drug: sugemalimab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Interventions
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Intervention Details:
  • Drug: sugemalimab
    sugemalimab (Anti-PD-L1 antibody)
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05131438


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
EQRx International, Inc.
More Information
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Responsible Party: EQRx International, Inc.
ClinicalTrials.gov Identifier: NCT05131438    
Other Study ID Numbers: EQ165-501
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Keywords provided by EQRx International, Inc.:
relapsed/refractory
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin