| Eligibility |
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.
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