Sepsis, SeverePhase 2IRIS-7-C&DNCT03821038
Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients
A Phase 2 study testing CYT107 in people with Sepsis, Severe, run by Revimmune at 10 sites in 2 countries.
Trial summary
This phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A\&B study which was conducted in the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis, Severe
- What is being tested?
- CYT107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Jun 2019to 6 Oct 2021
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A written, signed informed consent, by the patient or the patient's legally authorized representative
- Participants with an absolute lymphocyte count (ALC) ≤ 900 cells/mm3, at two time points at least twelve hours apart, following diagnosis of vasopressor dependent sepsis and,
- the second time point should not be performed earlier than 48 hours after sepsis diagnosis,
- study drug treatment initiation is required no later than 120 hours (up to 5 days) after the last qualifying ALC ≤ 900 cells/mm3 measure, and
- the average value of the two qualifying ALC counts will serve as a baseline to express the percent increase at day 29, or at hospital discharge.
- Patients in the ICU with onset of vasopressor dependent sepsis defined as hypotension requiring treatment with any vasopressor(s) for at least 6 hours to maintain a systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥65 mmHg AND at least 1 of the 2 organ dysfunction criteria below:
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- Acute respiratory failure defined as the need for invasive mechanical ventilation for at least 24 hours to support pulmonary function
- Acute kidney injury defined as creatinine > 2.0 mg/dL (based on new abnormal result following onset of sepsis) OR urine output < 0.5 mL/kg/hr for > 4 hours despite adequate fluid resuscitation. In the presence of pre-existing impairment of renal function (defined as a serum creatinine concentration >2 times the upper limit of the normal reference range prior to the onset of sepsis), the patient must meet the other organ dysfunction criteria.
- Anticipated hospital duration of up to approx. three weeks after initiating study drug treatment to allow 6 study drug administrations (Days 18 or 19 would be final dose)
- This study permits the re-enrollment of a participant who may have been discontinued as a pre-treatment screen failure and/or prior to study drug treatment.
- Age and reproductive status:
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment
- Women must not be breastfeeding
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with CYT107 plus 5 half-lives of CYT107 (the terminal half-life of CYT107 is up to 2 days) plus 30 days (duration of ovulatory cycle) for a total of 2 months post-treatment completion.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with CYT107 plus 5 half-lives of CYT107 plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.
- Azoospermic males are exempt from contraceptive requirements.
- WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements but still must undergo pregnancy testing.
Who cannot join
- Cancer with current chemotherapy or radiotherapy (receipt of chemotherapy or radiotherapy for cancer within the last 6 weeks). All patients with current, or history of, hematologic malignancy (including, but not limited to, ALL, AML, CLL, CML, etc.) or lymphoma will be excluded, regardless of receipt of recent chemotherapy
- Patients with minimal chance of survival and life expectancy less than 3-5 days as defined by an APACHE II score of ≥ 35 at time of consideration for study eligibility
- Patients with history or current evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.
- Patients who have received a solid organ transplant or bone marrow transplant.
- Patients with active or a history of acute or chronic lymphocytic leukemia
- AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
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- Known history of chronic HBV infection and not on treatment with HBV nucleoside analogues prior to the current hospitalization or HBV DNA > 100 IU/mL
- Known history of infection with HCV and currently undergoing treatment for HCV infections or has detectable HCV RNA
- Known history of tuberculosis and currently undergoing treatment for tuberculosis
- History of splenectomy
- Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia
- Participation in another investigational interventional study testing a drug or a medical device within the last 3 months prior to study entry
- Patients receiving immunosuppressive drugs, e.g., TNF-alpha inhibitors, for any reason, or systemic corticosteroids other than hydrocortisone at a dose of 300 mg/day
- Patients receiving concurrent immunotherapy or biologic agents; including growth factors, cytokines and interleukins other than the study medication : IL-2, Interferons α, β and γ, GM-CSF, G-CSF, HIV vaccines, immunosuppressive drugs, hydroxyurea, immunoglobulins, adoptive cell therapy
- Prior exposure to IL 7 or other drugs specifically targeting T cells
- Presence of an advanced directive to withhold or withdraw life-sustaining treatment, DNR order or no CPR order, or comfort measures only order
- Patients for whom prognosis is poor and source control of septic event is considered unlikely per the clinical and research teams.
- Patients under guardianship
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
France8 sites
CHU Angers
Angers, 49933
Hopital HENRI MONDOR
Créteil, 94300
CHU Dijon Bourgogne
Dijon, 21000
University Hospital of Limoges
Limoges, 87042
Hôpital Edouard Herriot
Lyon, 69003
Chr Orleans
Orléans, 45067
Hopital COCHIN
Paris, 75014
Chru Bretonneau
Tours, 37044
United States2 sites
University of Florida
Gainesville, Florida, 32610-0108
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis
This phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients
The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A\&B study which was conducted in the same patient population.
Read the detailed description
Lymphopenic sepsis Patients will be randomized 3:1 to receive either:
- Intravenous (IV) administration of CYT107 at 10 μg/kg twice a week for 3 weeks or b) IV placebo (normal saline).
The effect of CYT107 on Lymphocyte and various T cell populations will be documented with a focus on the first 29 days.
Stopping rules will apply if ALC increases to >2.5 times the upper limit of normal range.
The IRIS-7C \& D studies will be conducted at multiple sites in France and the United States. All sites will use the same study design and similar study protocol for a common statistical analysis of 40 evaluable participants.
- Conditions
- Sepsis, Severe
- Being tested
- CYT107, Placebos
- Keywords
- Sepsis, IL-7, lymphocytopenia
- Medical subject headings
- Sepsis, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT107Biological
Also called human recombinant glycosylated Interleukin-7
IV twice a week at 10µg/kg for 3 weeks
PlacebosDrug
Also called saline solution
IV twice a week at the same volume for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CYT107 | Experimental | Intravenous (IV) administration of CYT107 at 10 μg/kg twice a week for 3 weeks Receives: Biological: CYT107 |
| Placebo | Placebo comparator | Intravenous (IV) administration of the same volume of NaCl 0.9% twice a week for 3 weeks Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte reconstitution
Change in absolute lymphocyte count (ALC) of ≥ 50%. If this 50% increase over baseline is reached in the placebo group due to natural immune reconstitution, then the day 29 percent increase of ALC over baseline will be compared between the two groups.
Measured: day 29 versus baseline
Secondary outcomes (20)
adverse events
Incidence and scoring of all grade 3-4 adverse events
Measured: 90 days after study treatment initiation
Secondary Infections
Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC)
Measured: within 90 days after treatment initiation
Days in the ICU
Number of days in ICU following study treatment initiation during the index hospitalization
Measured: within 90 days after treatment initiation
readmissions to the ICU
Number of readmissions to ICU following study treatment initiation during index hospitalization
Measured: within 90 days after treatment initiation
organ support free days
Number of organ support free days (OSFDs) following study treatment initiation during the index hospitalization
Measured: within 90 days after treatment initiation
re-hospitalization
the incidence of re-hospitalization
Measured: within 90 days following study treatment initiation
Mortality rate
All-cause mortality
Measured: 90 days after study treatment initiation
T cell reconstitution
Absolute numbers of CD4+ and CD8+T-cell counts
Measured: through day 90
Percentage of patients reaching normal ALC
Percentage of patients reaching absolute lymphocyte counts (ALC) > 1200
Measured: through day 90
Quantification of IL-7 receptor
Effects on soluble and cellular IL-7 receptor (CD127) expression
Measured: through day 90
Quantification of HLA-DR on monocytes
Effects on circulating monocyte HLA-DR expression
Measured: through day 90
Change of IL-6 blood levels
Effects on whole blood circulating cytokines IL-6
Measured: through day 90
Change of IL-10 blood levels
Effects on whole blood circulating IL-10
Measured: through day 90
Change of TNF-α blood levels
Effects on whole blood circulating TNF-α
Measured: through day 90
CYT107 Pharmacokinetic Tmax
determination of Tmax
Measured: Day 1 and Day 15
CYT107 Pharmacokinetic Cmax
determination of Cmax
Measured: Day 1 and Day 15
CYT107 Pharmacokinetic half life
determination of half-life
Measured: Day 1 and Day 15
CYT107 Pharmacokinetic clearance
determination of clearance
Measured: Day 1 and Day 15
CYT107 Pharmacokinetic area under curve
determination of area under curve
Measured: Day 1 and Day 15
anti-CYT107 antibodies
Quantification of circulating anti-CYT107 antibodies
Measured: day 1, day 29 or hospital discharge, day 90 and day 180 if previous sample positive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Jun 2019
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Why it stopped: PK issue detected after bolus IV route administration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sepsis, SevereStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multicenter, randomized, double-blinded placebo- controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, University Hospital, Limoges, Emerald Clinical Inc.
- Responsible party
- Sponsor
- Investigators
- Richard Hotchkiss, MD, Principal investigator, Washington University School of MedicineBruno François, MD, Principal investigator, Limoges Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821038
- Sponsor's protocol ID
- IRIS-7-C&D
- Acronym
- IRIS-7-C&D
- Status last verified
- Oct 2021
- First submitted
- 24 Jan 2019
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be published Individual data can't be shared and are protected by the new GDPR rule
Publications
Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmele T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5):e98960. doi: 10.1172/jci.insight.98960.
PubMed 29515037Daix T, Mathonnet A, Brakenridge S, Dequin PF, Mira JP, Berbille F, Morre M, Jeannet R, Blood T, Unsinger J, Blood J, Walton A, Moldawer LL, Hotchkiss R, Francois B. Intravenously administered interleukin-7 to reverse lymphopenia in patients with septic shock: a double-blind, randomized, placebo-controlled trial. Ann Intensive Care. 2023 Mar 12;13(1):17. doi: 10.1186/s13613-023-01109-w.
PubMed 36906875
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT03821038
- Acronym / sponsor ID
- IRIS-7-C&D / IRIS-7-C&D
- Conditions
- Sepsis, Severe
- Keywords
- Sepsis, IL-7, lymphocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PK issue detected after bolus IV route administration
- Enrolment
- 21 participants (actual)
- Lead sponsor
- RevimmuneIndustry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, University Hospital, Limoges, Emerald Clinical Inc.
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 29 Jan 2019 (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 phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients
The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A\&B study which was conducted in the same patient population.
Detailed description
Lymphopenic sepsis Patients will be randomized 3:1 to receive either:
- Intravenous (IV) administration of CYT107 at 10 μg/kg twice a week for 3 weeks or b) IV placebo (normal saline).
The effect of CYT107 on Lymphocyte and various T cell populations will be documented with a focus on the first 29 days.
Stopping rules will apply if ALC increases to >2.5 times the upper limit of normal range.
The IRIS-7C \& D studies will be conducted at multiple sites in France and the United States. All sites will use the same study design and similar study protocol for a common statistical analysis of 40 evaluable participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- International, multicenter, randomized, double-blinded placebo- controlled
| Arm | Type | Receives |
|---|---|---|
| CYT107 | Experimental | Biological: CYT107Intravenous (IV) administration of CYT107 at 10 μg/kg twice a week for 3 weeks |
| Placebo | Placebo comparator | Drug: PlacebosIntravenous (IV) administration of the same volume of NaCl 0.9% twice a week for 3 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A written, signed informed consent, by the patient or the patient's legally authorized representative
- Participants with an absolute lymphocyte count (ALC) ≤ 900 cells/mm3, at two time points at least twelve hours apart, following diagnosis of vasopressor dependent sepsis and,
- Patients in the ICU with onset of vasopressor dependent sepsis defined as hypotension requiring treatment with any vasopressor(s) for at least 6 hours to maintain a systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥65 mmHg AND at least 1 of the 2 organ dysfunction criteria below:
- Anticipated hospital duration of up to approx. three weeks after initiating study drug treatment to allow 6 study drug administrations (Days 18 or 19 would be final dose)
- This study permits the re-enrollment of a participant who may have been discontinued as a pre-treatment screen failure and/or prior to study drug treatment.
Key exclusion criteria (18 listed)
- Cancer with current chemotherapy or radiotherapy (receipt of chemotherapy or radiotherapy for cancer within the last 6 weeks). All patients with current, or history of, hematologic malignancy (including, but not limited to, ALL, AML, CLL, CML, etc.) or lymphoma will be excluded, regardless of receipt of recent chemotherapy
- Patients with minimal chance of survival and life expectancy less than 3-5 days as defined by an APACHE II score of ≥ 35 at time of consideration for study eligibility
- Patients with history or current evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.
- Patients who have received a solid organ transplant or bone marrow transplant.
- Patients with active or a history of acute or chronic lymphocytic leukemia
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 |
|---|---|---|
| CYT107Also: human recombinant glycosylated Interleukin-7IV twice a week at 10µg/kg for 3 weeks | Biological | CYT107 |
| PlacebosAlso: saline solutionIV twice a week at the same volume for 3 weeks | Drug | Placebo |
Primary outcome
Lymphocyte reconstitution
Time frame: day 29 versus baseline
Change in absolute lymphocyte count (ALC) of ≥ 50%. If this 50% increase over baseline is reached in the placebo group due to natural immune reconstitution, then the day 29 percent increase of ALC over baseline will be compared between the two groups.
20 secondary outcomes
adverse events
Time frame: 90 days after study treatment initiation
Secondary Infections
Time frame: within 90 days after treatment initiation
Days in the ICU
Time frame: within 90 days after treatment initiation
readmissions to the ICU
Time frame: within 90 days after treatment initiation
organ support free days
Time frame: within 90 days after treatment initiation
re-hospitalization
Time frame: within 90 days following study treatment initiation
Mortality rate
Time frame: 90 days after study treatment initiation
T cell reconstitution
Time frame: through day 90
Percentage of patients reaching normal ALC
Time frame: through day 90
Quantification of IL-7 receptor
Time frame: through day 90
Quantification of HLA-DR on monocytes
Time frame: through day 90
Change of IL-6 blood levels
Time frame: through day 90
Change of IL-10 blood levels
Time frame: through day 90
Change of TNF-α blood levels
Time frame: through day 90
CYT107 Pharmacokinetic Tmax
Time frame: Day 1 and Day 15
CYT107 Pharmacokinetic Cmax
Time frame: Day 1 and Day 15
CYT107 Pharmacokinetic half life
Time frame: Day 1 and Day 15
CYT107 Pharmacokinetic clearance
Time frame: Day 1 and Day 15
CYT107 Pharmacokinetic area under curve
Time frame: Day 1 and Day 15
anti-CYT107 antibodies
Time frame: day 1, day 29 or hospital discharge, day 90 and day 180 if previous sample positive
Results and safety
The study was stopped early (reason given: PK issue detected after bolus IV route administration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Background: PubMed 29515037Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmele T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5):e98960. doi: 10.1172/jci.insight.98960.
- Derived from this study: PubMed 36906875Daix T, Mathonnet A, Brakenridge S, Dequin PF, Mira JP, Berbille F, Morre M, Jeannet R, Blood T, Unsinger J, Blood J, Walton A, Moldawer LL, Hotchkiss R, Francois B. Intravenously administered interleukin-7 to reverse lymphopenia in patients with septic shock: a double-blind, randomized, placebo-controlled trial. Ann Intensive Care. 2023 Mar 12;13(1):17. doi: 10.1186/s13613-023-01109-w.
- Individual participant dataSharing planned: No. Study results will be published Individual data can't be shared and are protected by the new GDPR rule
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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.
Richard Hotchkiss, MD principal investigator
Washington University School of Medicine
Bruno François, MD principal investigator
Limoges Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT107 in people with Sepsis, Severe, run by Revimmune at 10 sites in 2 countries.
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 17 inclusion and 18 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: stopped early, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: PK issue detected after bolus IV route administration). 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.
What does the primary outcome measure?
Lymphocyte reconstitution (time frame: day 29 versus baseline). 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 NCT03821038, which also lists 2 linked publications.
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 Oct 2021.