Natural Killer/T-cell LymphomaPhase 2ICINGNCT04763616
Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy
A Phase 2 study testing Isatuximab and Cemiplimab in people with Natural Killer/T-cell Lymphoma and Relapsed Natural Killer/T-cell Lymphoma, run by Won Seog Kim at 1 site in South Korea.
Trial summary
This study is to analyze the efficacy of PD1 inhibitor and anti-CD38 antibody in relapsed or refractory NK/T-cell lymphoid malignancy. The investigational products of this study are cemiplimab (PD1 inhibitor) and isatuximab (anti-CD38 antibody). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Natural Killer/T-cell Lymphoma, Relapsed Natural Killer/T-cell Lymphoma, Refractory Natural Killer/T-cell Lymphoma
- What is being tested?
- Isatuximab and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2021to 1 Apr 2026
- Phase
- Phase 2
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should be histologically diagnosed with extranodal NK/T-cell lymphoma or aggressive NK-cell leukemia.
- Patient should be previously treated with at least one type of chemotherapy regimen including autologous stem cell transplantation.
- Patient should have relapsed or refractory disease before enrollment.
- Patient written informed consent obtained prior to any screening procedures.
- Patient should be a male or female ≥ 19 years (Maximum 85 years)
- Patient should have at least one measurable lesion on the CT or PET/CT scan. In case of PET/CT, diagnostic quality CT part of PET/CT is needed to define measurability. Cf. If a patient only has non-measurable lesion on the CT or PET/CT scan (e.g. bone marrow involvement, malignant effusion, and hemophagocytic lymphohistiocytosis), its association with disease progression or relapse should be determined by an investigator. Based on investigators' decision, patients with non-measurable lesion could be enrolled.
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- Patient should have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 which is not declining during the last 2 weeks before the signature of the main study Informed Consent Form (S-ICF).
- Patient should have adequate bone marrow function as defined by the following laboratory values: Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L; Platelets ≥ 50 x 109/L; Hemoglobin ≥ 8.0 g/dL Cf. If the cause of cytopenia is related with bone marrow involvement of tumor cells, a patient could be enrolled after blood transfusion or G-CSF support by investigator's decision.
- Female patient should fulfill the following criteria 1) Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential; 2) Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 6 months after last administration of study drug if the risk of conception exists.
- Patient should have adequate organ function as defined by the following laboratory values: Serum Creatinine ≤ 2.0 × ULN; Serum Bilirubin ≤ 2.0 × ULN; AST and ALT ≤ 3 × ULN. Cf. If the values of liver function tests more than the above-mentioned criteria are related with disease relapse or progression to liver, a patient could be enrolled by investigator's decision in case of ≤ 5.0 × ULN.
- Patients should have archived tumor tissue or fresh tissue sample obtained from re-biopsy at relapse available for targeted sequencing.
- In case of written consent to participation in clinical study: Must sign the subject consent form that states the blood sampling done according to the study protocol and that the subject has comprehended the purpose and the necessary procedures of clinical study with intention to participate in the clinical study (or signed by the subject's representative).
Who cannot join
- Patient has history of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
- Patient has a concurrent malignancy or has had a malignancy in the last 3 years prior to start of study treatment (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
- Patient has had major surgery within 21 days prior to starting study drug or has not recovered from major side effects of the surgery
- Patient with current use of immunosuppressive medication, EXCEPT for the following: - Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) - Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent - Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). The use of 10 mg or more of prednisolone may be acceptable for adrenal insufficiency according to the investigator's judgment.
- Patient has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication including any of the following: - Left Ventricular Ejection Fraction (LVEF) < 50% as determined by echocardiogram - QTc > 480 msec on screening ECG (using the QTcF formula) - Unstable angina pectoris - Ventricular arrhythmias except for benign premature ventricular contractions - Supraventricular and nodal arrhythmias not controlled with medication - Conduction abnormality requiring a pacemaker - Valvular disease with documented compromise in cardiac function
- Patient has known history of testing positive for HIV or known acquired immunodeficiency syndrome
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- Patient has known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v.5.0 Grade ≥ 3).
- Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g. uncontrolled diabetes, chronic pancreatitis, active chronic hepatitis etc.). Other severe acute or chronic medical conditions include colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator. Cf. "Persisting toxicity related to prior therapy (NCI CTCAE v.5.0 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable."
- Patient has active infection requiring systemic therapy
- Patient has prior organ transplantation including allogenic stem-cell transplantation
- Patient has active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. However, patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible
- Patient is not able to understand or to comply with study instructions and requirements or has a history of non-compliance to medical regimen.
- Patient is a pregnant or nursing (lactating) woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test (> 5 mIU/mL).
- Vaccination within 4 weeks of the first dose of isatuximab and cemiplimab, and while on trials is prohibited except for administration of inactivated vaccines.
- Patient has hepatitis B virus (HBV) associated liver disease as follows - Liver cirrhosis and chronic hepatitis with HBV reactivation - Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
- Prior treatment with an agent (approved or investigational) that blocks either PD1/PDL1 or CD38 (participants who joined a study with an anti-CD38 or anti-PD1/PDL1 but have written confirmation they were on control arm are allowed).
- Wash out period of less than 2 weeks from previous antitumor chemotherapy, tyrosine kinase inhibitor immunotherapy, or any palliative radiotherapy; less than 4 weeks from previous antitumor biological therapy (e.g., rituximab and brentuximab vedotin).
- Participant has received wide field radiotherapy ≤4 weeks prior to starting study treatment, or limited field radiation for palliation ≤2 weeks prior to starting study treatment, or has not recovered from the side effects of such therapy.
- Last dose of prior investigational agent within 28 days from initiation of study intervention.
- Predicted life expectancy is less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy : Nick Name - ICING Study
This study is to analyze the efficacy of PD1 inhibitor and anti-CD38 antibody in relapsed or refractory NK/T-cell lymphoid malignancy. The investigational products of this study are cemiplimab (PD1 inhibitor) and isatuximab (anti-CD38 antibody).
The rationale for the use of cemiplimab in patients with NK/T-cell lymphoid malignancy is the aforementioned PD-L1 expression in tumor cells of ENKTL and ANKL. In addition, the proven efficacy of pembrolizumab in relapsed or refractory ENKTL support the use of PD1 inhibitor as a salvage therapy for this disorder.
Read more
The addition of isatuximab to cemiplimab might induce synergistic activity because CD38-mediated immunosuppression as a mechanism of tumor cell escape from PD-1/PD-L1 blockade. Furthermore, targeting CD38 by isatuximab can preferentially block immunosuppressive regulatory T-cells and thereby restore immune effector function against multiple myeloma. These functions of CD38 blocking antibody might help to improve the efficacy of immune checkpoint inhibitor such as PD1 inhibitor.
Given the presence of antibody-mediated cytotoxicity and direct anti-tumor effect of isatuximab against CD38-positive tumor cells, the combination of isatuximab with cemiplimab might show the synergistic activity resulting more improved treatment outcome than PD1 inhibitor alone.
Thus, The investigators designed a phase II study of cemiplimab and isatuximab for patients with relapsed or refractory ENKTL and ANKL. In this study, The investigators analyze the efficacy of this novel combination and their adverse effects.
Read the detailed description
This clinical trial is a study that uses two antibodies called 'Isatuximab' and 'Cemiplemab' as a rescue anticancer therapy for patients with relapsed or refractory'NK/T cell lymphoma'.
Cemiplimab is an antibody against the PD1 protein of cytotoxic T cells. By inhibiting the binding of the PDL1 protein expressed on the surface of tumor cells, cancer cells use the PDL1 protein expressed on the surface of their cells to the tumor immune function It works to prevent getting involved.
When the interaction between PD1 and PDL1 protein is suppressed in this way, T cells in human's body attack and kill cancer cells, and cancer cells are killed through this process.
To date, immuno-cancer drugs that inhibit the interaction of PD1 and PDL1 proteins have already been developed other than Cemiplimab, and have proven excellent therapeutic effects in lung cancer and Hodgkin's lymphoma.
Therefore, the investigators have started this clinical trial because Cemiplimab, one of the immuno-cancer drugs, is expected to be effective in the 'NK/T cell lymphoma' that you have been diagnosed with. However, the effect of Cemiplimab in the disease has not yet been proven, and a research report has recently been published that other anticancer drugs that inhibit the PD1 protein may be effective in'extralymphatic NK/T cell lymphoma'.
However, this is not conclusive because it is a study involving a small number of patients.
However, if this clinical trial proves that cemiplimab is effective in 'NK/T cell lymphoma', it could contribute to the development of new treatments for this disease. In addition, all of the previous studies have studied the therapeutic effect using only a single antibody that inhibits the PD1 protein, but in this study, an antibody against the CD38 antigen called isatuximab is used together. The CD38 antigen is expressed in several hematocrit cells, and in multiple myeloma, antibodies to CD38 are already used as standard treatments for relapsed or refractory diseases. However, the high frequency of expression of CD38 antigen on the surface of tumor cells of NK/T cell lymphoma is expected as a therapeutic target, but its therapeutic effect has not yet been proven. Istuximab used in this study is an antibody targeting CD38, and can be expected to kill tumor cells expressing CD38, so when administered in combination with cemiplimab, its therapeutic effect can be increased. In this study, patients diagnosed and treated as'NK/T cell lymphoma' but did not reach cure and the disease worsened, or patients who experienced a cure but later recurred. The investigators want to evaluate the effectiveness.
Through this, the goal is to improve the prognosis by discovering a new treatment that is ultimately effective for the treatment of relapsed or refractory 'NK/T cell lymphoma.'
- Conditions
- Natural Killer/T-cell Lymphoma, Relapsed Natural Killer/T-cell Lymphoma, Refractory Natural Killer/T-cell Lymphoma
- Being tested
- Isatuximab, Cemiplimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
The treatment cycle will be repeated up to 2 years. If a patient shows disease progression or unacceptable toxicity, the study treatment will be discontinued and followed up for efficacy and safety after the discontinuation of study treatment.
CemiplimabDrug
The treatment cycle will be repeated up to 2 years. If a patient shows disease progression or unacceptable toxicity, the study treatment will be discontinued and followed up for efficacy and safety after the discontinuation of study treatment.
| Study group | Role | What they receive |
|---|---|---|
| Isatuximab and Cemiplimab combined therapy | Experimental | Drug : Isatuximab
1 cycle : 10mg/kg IV every week. It is administered on Day 2, Day 9, Day 16, Day 23.
2~6 cycle : 10mg/kg every 2 weeks . It is administered on Day 2, Day 16.
7th cycle and beyond : 10mg/kg IV every 3 weeks. It is administered on Day 2.
Drug : Cemiplimab
1st - 6th cycle : 250mg IV every 2 weeks. It is administered on Day 1, Day 15.
7th cycle and beyond : 350mg every 3 weeks. It is administered on Day 1. Receives: Drug: Isatuximab; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
The percentage of subjects with complete response (CR)
Measured: 3 years after completion of the clinical trial drug administration of the last subject
Secondary outcomes (4)
Incidence of Adverse Events [Safety and Tolerability]).
Investigation of Adverse evensts occurred in subject
Measured: 3 years after completion of the clinical trial drug administration of the last subject
Progression-free survival rate
Time between the date of treatment start and the date of death due to any cause or date of disease progression.
Measured: 3 years after completion of the clinical trial drug administration of the last subject
Overall survival rate
Time between the date of treatment start and the date of death due to any cause.
Measured: 3 years after completion of the clinical trial drug administration of the last subject
Disease control rate
complete response, partial response
Measured: 3 years after completion of the clinical trial drug administration of the last subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start25 Jun 2021
- Primary completion30 Apr 2023
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Natural Killer/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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Won Seog Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Wonseog Kim, MD, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763616
- Sponsor's protocol ID
- 2020-10-038
- Acronym
- ICING
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim SJ, Lim JQ, Yoon SE, Yang DH, Lee JH, Oh SY, Choi YS, Jeong SH, Kim MK, Lim SN, Cho J, Park B, Ryu KJ, Choi S, Park Y, Huifen Lim KM, Binte Muhammad Taib NA, Ong CK, Lim ST, Kim WS. Efficacy of combined CD38 and PD-1 inhibition with isatuximab and cemiplimab for relapsed/refractory NK/T-cell lymphoma. Blood. 2025 Jul 10;146(2):155-166. doi: 10.1182/blood.2024027109.
PubMed 40073374
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy : Nick Name - ICING Study
- ClinicalTrials.gov ID
- NCT04763616
- Acronym / sponsor ID
- ICING / 2020-10-038
- Conditions
- Natural Killer/T-cell Lymphoma, Relapsed Natural Killer/T-cell Lymphoma, Refractory Natural Killer/T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Won Seog KimUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 21 Feb 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 study is to analyze the efficacy of PD1 inhibitor and anti-CD38 antibody in relapsed or refractory NK/T-cell lymphoid malignancy. The investigational products of this study are cemiplimab (PD1 inhibitor) and isatuximab (anti-CD38 antibody).
The rationale for the use of cemiplimab in patients with NK/T-cell lymphoid malignancy is the aforementioned PD-L1 expression in tumor cells of ENKTL and ANKL. In addition, the proven efficacy of pembrolizumab in relapsed or refractory ENKTL support the use of PD1 inhibitor as a salvage therapy for this disorder.
The addition of isatuximab to cemiplimab might induce synergistic activity because CD38-mediated immunosuppression as a mechanism of tumor cell escape from PD-1/PD-L1 blockade. Furthermore, targeting CD38 by isatuximab can preferentially block immunosuppressive regulatory T-cells and thereby restore immune effector function against multiple myeloma. These functions of CD38 blocking antibody might help to improve the efficacy of immune checkpoint inhibitor such as PD1 inhibitor.
Given the presence of antibody-mediated cytotoxicity and direct anti-tumor effect of isatuximab against CD38-positive tumor cells, the combination of isatuximab with cemiplimab might show the synergistic activity resulting more improved treatment outcome than PD1 inhibitor alone.
Thus, The investigators designed a phase II study of cemiplimab and isatuximab for patients with relapsed or refractory ENKTL and ANKL. In this study, The investigators analyze the efficacy of this novel combination and their adverse effects.
Detailed description
This clinical trial is a study that uses two antibodies called 'Isatuximab' and 'Cemiplemab' as a rescue anticancer therapy for patients with relapsed or refractory'NK/T cell lymphoma'.
Cemiplimab is an antibody against the PD1 protein of cytotoxic T cells. By inhibiting the binding of the PDL1 protein expressed on the surface of tumor cells, cancer cells use the PDL1 protein expressed on the surface of their cells to the tumor immune function It works to prevent getting involved.
When the interaction between PD1 and PDL1 protein is suppressed in this way, T cells in human's body attack and kill cancer cells, and cancer cells are killed through this process.
To date, immuno-cancer drugs that inhibit the interaction of PD1 and PDL1 proteins have already been developed other than Cemiplimab, and have proven excellent therapeutic effects in lung cancer and Hodgkin's lymphoma.
Therefore, the investigators have started this clinical trial because Cemiplimab, one of the immuno-cancer drugs, is expected to be effective in the 'NK/T cell lymphoma' that you have been diagnosed with. However, the effect of Cemiplimab in the disease has not yet been proven, and a research report has recently been published that other anticancer drugs that inhibit the PD1 protein may be effective in'extralymphatic NK/T cell lymphoma'.
However, this is not conclusive because it is a study involving a small number of patients.
However, if this clinical trial proves that cemiplimab is effective in 'NK/T cell lymphoma', it could contribute to the development of new treatments for this disease. In addition, all of the previous studies have studied the therapeutic effect using only a single antibody that inhibits the PD1 protein, but in this study, an antibody against the CD38 antigen called isatuximab is used together. The CD38 antigen is expressed in several hematocrit cells, and in multiple myeloma, antibodies to CD38 are already used as standard treatments for relapsed or refractory diseases. However, the high frequency of expression of CD38 antigen on the surface of tumor cells of NK/T cell lymphoma is expected as a therapeutic target, but its therapeutic effect has not yet been proven. Istuximab used in this study is an antibody targeting CD38, and can be expected to kill tumor cells expressing CD38, so when administered in combination with cemiplimab, its therapeutic effect can be increased. In this study, patients diagnosed and treated as'NK/T cell lymphoma' but did not reach cure and the disease worsened, or patients who experienced a cure but later recurred. The investigators want to evaluate the effectiveness.
Through this, the goal is to improve the prognosis by discovering a new treatment that is ultimately effective for the treatment of relapsed or refractory 'NK/T cell lymphoma.'
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isatuximab and Cemiplimab combined therapy | Experimental | Drug: Isatuximab, Drug: CemiplimabDrug : Isatuximab 1 cycle : 10mg/kg IV every week. It is administered on Day 2, Day 9, Day 16, Day 23. 2~6 cycle : 10mg/kg every 2 weeks . It is administered on Day 2, Day 16. 7th cycle and beyond : 10mg/kg IV every 3 weeks. It is administered on Day 2. Drug : Cemiplimab 1st - 6th cycle : 250mg IV every 2 weeks. It is administered on Day 1, Day 15. 7th cycle and beyond : 350mg every 3 weeks. It is administered on Day 1. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients should be histologically diagnosed with extranodal NK/T-cell lymphoma or aggressive NK-cell leukemia.
- Patient should be previously treated with at least one type of chemotherapy regimen including autologous stem cell transplantation.
- Patient should have relapsed or refractory disease before enrollment.
- Patient written informed consent obtained prior to any screening procedures.
- Patient should be a male or female ≥ 19 years (Maximum 85 years)
Key exclusion criteria (20 listed)
- Patient has history of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
- Patient has a concurrent malignancy or has had a malignancy in the last 3 years prior to start of study treatment (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
- Patient has had major surgery within 21 days prior to starting study drug or has not recovered from major side effects of the surgery
- Patient with current use of immunosuppressive medication, EXCEPT for the following: - Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) - Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent - Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). The use of 10 mg or more of prednisolone may be acceptable for adrenal insufficiency according to the investigator's judgment.
- Patient has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication including any of the following: - Left Ventricular Ejection Fraction (LVEF) < 50% as determined by echocardiogram - QTc > 480 msec on screening ECG (using the QTcF formula) - Unstable angina pectoris - Ventricular arrhythmias except for benign premature ventricular contractions - Supraventricular and nodal arrhythmias not controlled with medication - Conduction abnormality requiring a pacemaker - Valvular disease with documented compromise in cardiac function
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 |
|---|---|---|
| IsatuximabThe treatment cycle will be repeated up to 2 years. If a patient shows disease progression or unacceptable toxicity, the study treatment will be discontinued and followed up for efficacy and safety after the discontinuation of study treatment. | Drug | Isatuximab and Cemiplimab combined therapy |
| CemiplimabThe treatment cycle will be repeated up to 2 years. If a patient shows disease progression or unacceptable toxicity, the study treatment will be discontinued and followed up for efficacy and safety after the discontinuation of study treatment. | Drug | Isatuximab and Cemiplimab combined therapy |
Primary outcome
Complete response rate
Time frame: 3 years after completion of the clinical trial drug administration of the last subject
The percentage of subjects with complete response (CR)
4 secondary outcomes
Incidence of Adverse Events [Safety and Tolerability]).
Time frame: 3 years after completion of the clinical trial drug administration of the last subject
Progression-free survival rate
Time frame: 3 years after completion of the clinical trial drug administration of the last subject
Overall survival rate
Time frame: 3 years after completion of the clinical trial drug administration of the last subject
Disease control rate
Time frame: 3 years after completion of the clinical trial drug administration of the last subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 40073374Kim SJ, Lim JQ, Yoon SE, Yang DH, Lee JH, Oh SY, Choi YS, Jeong SH, Kim MK, Lim SN, Cho J, Park B, Ryu KJ, Choi S, Park Y, Huifen Lim KM, Binte Muhammad Taib NA, Ong CK, Lim ST, Kim WS. Efficacy of combined CD38 and PD-1 inhibition with isatuximab and cemiplimab for relapsed/refractory NK/T-cell lymphoma. Blood. 2025 Jul 10;146(2):155-166. doi: 10.1182/blood.2024027109.
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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.
Wonseog Kim, MD, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab and Cemiplimab in people with Natural Killer/T-cell Lymphoma and Relapsed Natural Killer/T-cell Lymphoma, run by Won Seog Kim at 1 site in South Korea.
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 12 inclusion and 20 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: finished, as of the sponsor's last update on 27 Apr 2026. 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Complete response rate (time frame: 3 years after completion of the clinical trial drug administration of the last subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763616, which also lists 1 linked publication.
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 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.