Extranodal NK/T-cell LymphomaNCT05131438
An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)
A study testing sugemalimab in people with Extranodal NK/T-cell Lymphoma, run by EQRx International, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma
- What is being tested?
- sugemalimab
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Who may be able to join
- Participants are eligible to receive sugemalimab as part of this EAP only if all the following criteria apply:
- Participants must be 18 to 99 years of age inclusive, at the time of signing the informed consent.
- 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.
- Participants who have a histologically confirmed ENKTL. Both nasal and non-nasal ENKTL are allowed.
- 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).
- 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.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Participants are not eligible to participate in the Sugemalimab ENKTL EAP if any of the following criteria apply:
- Participants with aggressive natural killer cell leukemia or ENKTL participants who have any degree of leukemic involvement.
- Participants with hemophagocytic lymphohistiocytosis.
- 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])
- 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.
- Participants with active, known or suspected autoimmune disease.
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- 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.
- Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
- Participants in the treating physician's opinion are not suitable for participating in this EAP.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
- Conditions
- Extranodal NK/T-cell Lymphoma
- Being tested
- sugemalimab
- Keywords
- relapsed/refractory
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugemalimabDrug
sugemalimab (Anti-PD-L1 antibody)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- EQRx International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131438
- Sponsor's protocol ID
- EQ165-501
- Status last verified
- Mar 2023
- First submitted
- 11 Nov 2021
- Last updated
- 27 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05131438
- Acronym / sponsor ID
- EQ165-501
- Conditions
- Extranodal NK/T-cell Lymphoma
- Keywords
- relapsed/refractory
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- EQRx International, Inc.Industry (pharma, biotech, devices)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants are eligible to receive sugemalimab as part of this EAP only if all the following criteria apply:
- Participants must be 18 to 99 years of age inclusive, at the time of signing the informed consent.
- 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.
- Participants who have a histologically confirmed ENKTL. Both nasal and non-nasal ENKTL are allowed.
- 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).
Key exclusion criteria (9 listed)
- Participants are not eligible to participate in the Sugemalimab ENKTL EAP if any of the following criteria apply:
- Participants with aggressive natural killer cell leukemia or ENKTL participants who have any degree of leukemic involvement.
- Participants with hemophagocytic lymphohistiocytosis.
- 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])
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sugemalimabsugemalimab (Anti-PD-L1 antibody) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugemalimab in people with Extranodal NK/T-cell Lymphoma, run by EQRx International, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.