Trial · NCT04893018
NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
NCT04893018, Phase 1, Terminated, Fred Hutchinson Cancer Center; results first posted 2024-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. NT-I7 for Kaposi Sarcoma in Patients With or Without HIV. Trials, record NCT04893018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04893018
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
- NCT number
- NCT04893018
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- AIDS-Related Kaposi Sarcoma, HIV Infection, Kaposi Sarcoma
- Interventions
- Efineptakin alfa
- First posted
- 2021-05-19
- Last updated
- 2024-06-27
- Results first posted
- 2024-06-27
- Limitations and caveats
- Enrollment for this study was terminated early due end of funding. Some of the planned statistical analyses were not performed.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | Up to 30 days after last dose of NT-I7, approximately 31 weeks total | Measured by Common Terminology Criteria for Adverse Events version 5.0. |
| Secondary | Objective Response Rate (ORR). | 12 months | Defined as the proportion of participants who achieved Complete Response (CR) or Partial Response (PR) according to modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group Criteria (ACTG) criteria. |
| Secondary | Duration of Response (DOR) | Up to 1 year | Measured in participants who obtain a partial response or better and defined as time from the best response within the first 36 weeks of therapy until disease progression or censoring. Kaplan Meier survival estimates constructed for each of these survival endpoints with 95% confidence intervals (CIs), for up to 1 year following initiation of treatment in all participants. |
| Secondary | Progression-free Survival (PFS) | Assessed up to 1 year | Defined as the time from administration of the first dose of NT-I7 until disease progression or death or censoring. Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs, for up to 1 year following initiation of treatment in all participants. |
| Secondary | Overall Survival (OS) | Assessed up to 1 year following initiation of treatment | From administration of the first dose of NT-I7 until death or censoring. Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs. |
| Secondary | Effect of NT-I7 on Kinetics of Absolute Lymphocyte Counts (ALC) in Blood | From pre-administration to each time point following first administration (1, 4, and 9 weeks) | For analysis of circulating lymphocytes, we will describe fold-change (median and range) in blood ALC. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline. |
| Secondary | Effect of NT-I7 on Kinetics of CD4+ T Cells in Blood. | From pre-administration to each time point following first administration (1, 4, and 9 weeks) | Described by fold-change (median and range) in blood CD4+ T cells. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline. |
| Secondary | Effect of NT-I7 on Kinetics of CD8+ T Cells in Blood. | From pre-administration to each time point following first administration (1, 4, and 9 weeks) | Described by fold-change (median and range) in blood CD8+ T cells. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline. |
| Other | Immunogenicity of NT-I7 | Up to 12 months after last dose of NT-I7 | The proportion of participants developing neutralizing antibodies will be summarized. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events | Up to 30 days after last dose of NT-I7, approximately 31 weeks total | Analysis is conducted on all enrolled participants who received at least one dose of NT-I7. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR). | 12 months | Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Up to 1 year | Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Assessed up to 1 year | Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Assessed up to 1 year following initiation of treatment | Analysis is conducted on all enrolled and treated participants. | months | MEDIAN |
| SECONDARY | Effect of NT-I7 on Kinetics of Absolute Lymphocyte Counts (ALC) in Blood | From pre-administration to each time point following first administration (1, 4, and 9 weeks) | Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy. | No units, median and IQR of ratios | MEDIAN |
| SECONDARY | Effect of NT-I7 on Kinetics of CD4+ T Cells in Blood. | From pre-administration to each time point following first administration (1, 4, and 9 weeks) | Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy. | No units, median and IQR of ratios | MEDIAN |
| SECONDARY | Effect of NT-I7 on Kinetics of CD8+ T Cells in Blood. | From pre-administration to each time point following first administration (1, 4, and 9 weeks) | Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy. | No units, median and IQR of ratios | MEDIAN |
| OTHER_PRE_SPECIFIED | Immunogenicity of NT-I7 | Up to 12 months after last dose of NT-I7 |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events | NT-I7 (Efineptakin Alfa) Dose Level 1 | 100 | percentage of participants | ||
| Percentage of Participants With Adverse Events | NT-I7 (Efineptakin Alfa) Dose Level 2 | 100 | percentage of participants | ||
| Objective Response Rate (ORR). | NT-I7 (Efineptakin Alfa) Dose Level 1 | Complete Response (CR) | 0 | Participants | |
| Objective Response Rate (ORR). | NT-I7 (Efineptakin Alfa) Dose Level 2 | Complete Response (CR) | 0 | Participants | |
| Objective Response Rate (ORR). | NT-I7 (Efineptakin Alfa) Dose Level 1 | Partial Response (PR) | 1 | Participants | |
| Objective Response Rate (ORR). | NT-I7 (Efineptakin Alfa) Dose Level 2 | Partial Response (PR) | 2 | Participants | |
| Objective Response Rate (ORR). | NT-I7 (Efineptakin Alfa) Dose Level 1 | Objective Response Rate (CR+PR) | 1 | Participants | |
| Objective Response Rate (ORR). | NT-I7 (Efineptakin Alfa) Dose Level 2 | Objective Response Rate (CR+PR) | 2 | Participants | |
| Duration of Response (DOR) | NT-I7 (Efineptakin Alfa) Dose Level 1 | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Response (DOR) | NT-I7 (Efineptakin Alfa) Dose Level 2 | NA | 95% Confidence Interval NA to NA | months |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NT-I7 (Efineptakin Alfa) Dose Level 1 | 6 | |
| Overall Study | STARTED | NT-I7 (Efineptakin Alfa) Dose Level 2 | 2 | |
| Overall Study | COMPLETED | NT-I7 (Efineptakin Alfa) Dose Level 1 | 2 | |
| Overall Study | COMPLETED | NT-I7 (Efineptakin Alfa) Dose Level 2 | 0 | |
| Overall Study | NOT COMPLETED | NT-I7 (Efineptakin Alfa) Dose Level 1 | 4 | |
| Overall Study | NOT COMPLETED | NT-I7 (Efineptakin Alfa) Dose Level 2 | 2 |
Source ClinicalTrials.gov
Adverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | NT-I7 (Efineptakin Alfa) Dose Level 1 | 2 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | NT-I7 (Efineptakin Alfa) Dose Level 2 | 1 | 2 | |
| other | Axillary lymphadenopathy | Blood and lymphatic system disorders | NT-I7 (Efineptakin Alfa) Dose Level 1 | 0 | 6 | |
| other | Axillary lymphadenopathy | Blood and lymphatic system disorders | NT-I7 (Efineptakin Alfa) Dose Level 2 | 1 | 2 | |
| other | Anal pain | Gastrointestinal disorders | NT-I7 (Efineptakin Alfa) Dose Level 1 | 0 | 6 | |
| other | Anal pain | Gastrointestinal disorders | NT-I7 (Efineptakin Alfa) Dose Level 2 | 1 | 2 | |
| other | Diarrhea | Gastrointestinal disorders | NT-I7 (Efineptakin Alfa) Dose Level 1 | 2 | 6 | |
| other | Diarrhea | Gastrointestinal disorders | NT-I7 (Efineptakin Alfa) Dose Level 2 | 0 | 2 | |
| other | Nausea | Gastrointestinal disorders | NT-I7 (Efineptakin Alfa) Dose Level 1 | 1 | 6 | |
| other | Nausea | Gastrointestinal disorders | NT-I7 (Efineptakin Alfa) Dose Level 2 | 1 | 2 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NT-I7 (Efineptakin Alfa) Dose Level 1 | 0 | 6 |
| Total, all-cause mortality | NT-I7 (Efineptakin Alfa) Dose Level 2 | 0 | 2 |
| Total, other adverse events | NT-I7 (Efineptakin Alfa) Dose Level 1 | 6 | 6 |
| Total, other adverse events | NT-I7 (Efineptakin Alfa) Dose Level 2 | 2 | 2 |
| Total, serious adverse events | NT-I7 (Efineptakin Alfa) Dose Level 1 | 1 | 6 |
| Total, serious adverse events | NT-I7 (Efineptakin Alfa) Dose Level 2 | 1 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39915263 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA154967 | Cancer Immunotherapy Trials Network Central Operations and Statistical Center | DAVIDSON, NANCY ELLEN | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 2017 to 2022 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NT-I7 (Efineptakin Alfa) Dose Level 1 vs NT-I7 (Efineptakin Alfa) Dose Level 2: deaths from any cause | Trial comparisons |
| NT-I7 (Efineptakin Alfa) Dose Level 1 vs NT-I7 (Efineptakin Alfa) Dose Level 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04893018
GET https://conductscience.org/api/trials/v1/NCT04893018/results?page=2