NT-I7 for Kaposi Sarcoma in Patients With or Without HIV

NCT04893018 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: CITN-17NCI-2021-01002UM1CA154967
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

This phase I trial studies the best dose and effects of NT-I7 in treating Kaposi sarcoma in patients with or without HIV. NT-I7 works by using a patient's immune system to fight cancer. It is made in a laboratory and is used to boost, direct, or restore the body's natural defenses against cancer. NT-I7 may work better in treating Kaposi sarcoma.

Conditions

AIDS-Related Kaposi Sarcoma; HIV Infection; Kaposi Sarcoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events

  Measured by Common Terminology Criteria for Adverse Events version 5.0.

  Up to 30 days after last dose of NT-I7, approximately 31 weeks total

Secondary Outcomes (7)

• Objective Response Rate (ORR).

  12 months

• Duration of Response (DOR)

  Up to 1 year

• Progression-free Survival (PFS)

  Assessed up to 1 year

• Overall Survival (OS)

  Assessed up to 1 year following initiation of treatment

• 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)

Other Outcomes (1)

• Immunogenicity of NT-I7

  Up to 12 months after last dose of NT-I7

Study Arms (1)

Treatment (efineptakin alfa)

EXPERIMENTAL

Patients receive efineptakin alfa IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Biological: Efineptakin alfa

Interventions

Efineptakin alfa BIOLOGICAL

Given IM

Also known as: 2026634-47-7, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc

Treatment (efineptakin alfa)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed Kaposi sarcoma
• Patients must have evaluable disease. Note: Kaposi sarcoma will be evaluated using a modified version (consistent with National Cancer Institute \[NCI\] studies) of the Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) Oncology Committee staging and response definitions for KS
• No upper or lower limit on the number of prior therapies or stage of disease
• HIV-positive patients must have been on effective anti-retroviral (ART) therapy for at least 3 months prior to enrollment, with persistent KS affecting quality of life due to either T1 disease or T0 disease with inadequate disease regression on ART alone
• HIV-positive patients must have undetectable HIV viral loads =\< 40 copies/mL measured using a Food and Drug Administration (FDA)-approved commercial assay with lower limit of detection between =\< 20 copies/mL and =\< 40 copies/mL
• Patients with visceral involvement must:
• Meet other eligibility criteria
• Have any/all associated tumor associated symptoms =\< grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) criteria; and/or

You may not qualify if:

• Patients must provide newly obtained core, punch, or excisional biopsy of a tumor lesion obtained up to 28 days prior to treatment initiation. An archival tumor sample obtained within 1 year of screening is allowed if pre treatment biopsy is deemed unsafe or technically not feasible
• Patients must be \>= 18 years of age on day of signing informed consent document. Because no dosing or adverse event data are currently available on the use of NT-I7 in patients \< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
• Leukocytes \>= 2,500/mcL
• Absolute neutrophil count \>= 1,000/mcL
• Platelets \>= 100,000/mcL
• Hemoglobin \>= 9/dL
• Total bilirubin =\< 1.5 institutional upper limit of normal (ULN) OR \< 3 x institutional ULN for Gilbert's syndrome or HIV protease inhibitors
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional ULN
• Creatinine =\< 2 x institutional ULN OR creatinine clearance \>= 60 mL/min/1.73 m\^2 by Cockcroft-Gault. At the discretion of the treating physician, a 24-hour urine creatinine clearance could be obtained and utilized as the gold standard if creatinine clearance by Cockcroft-Gault is \< 30 and prevents patient enrollment on the trial
• Patients with chronic hepatitis B virus (HBV) infection must be on suppressive antiviral therapy
• Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load due to prior treatment or natural resolution
• Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours before receiving the first dose of the study agent. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• The effects of NT-I7 on the developing human fetus are unknown. For this reason and because NT-I7 may have an adverse effect on pregnancy and poses risk to the human fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 90 days after completion of NT-I7 administration
• Ability to understand and the willingness to sign a written informed consent document

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Cancer Immunotherapy Trials Network (CITN): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Ramaswami R, Kask AS, D'Amico L, Menon MP, Lurain K, Yarchoan R, Ekwede I, Couey P, Burnham E, Angeldekao A, Ha Lee B, Kaiser JC, Cheever M, Uldrick TS, Kwok LL, Wright A, Fling SP, Wang CJ. Phase I study of efineptakin alfa (NT-I7) for the treatment of Kaposi sarcoma. J Immunother Cancer. 2025 Feb 6;13(2):e010291. doi: 10.1136/jitc-2024-010291.

  PMID: 39915263 DERIVED

MeSH Terms

Conditions

AIDS-related Kaposi sarcoma; HIV Infections; Sarcoma, Kaposi

Interventions

efineptakin alfa

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Limitations and Caveats

Enrollment for this study was terminated early due end of funding. Some of the planned statistical analyses were not performed.

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Cancer Immunotherapy Trials Network

citn.core.reg@hvtn.org

206-667-2541

Study Officials

• Chia-Ching (Jackie) Wang

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: May 23, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 27, 2024
• Results First Posted: June 27, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)