NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07052305
Phase
PHASE1
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NT-I7 — DRUG
    Provided by NeoImmune Tech
  • CAR T-cell therapy — BIOLOGICAL
    Standard of care: Will be given on day 0 and will be either axicabtagene ciloleucel or lisocabtagene maraleucel .

Study Details

Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed/refractory disease. CAR T-cell therapy has revolutionized modern cancer therapy, with axicabtagene ciloleucel and lisocabtagene maraleucel (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed/refractory large B-cell lymphoma. IL-7 plays a crucial role in T-cell homeostasis by inducing thymic differentiation, peripheral expansion, and extrathymic differentiation. It is the main regulator of T-cell hemostasis, inducing T-cell growth and proliferation in lymphopenic patients. There is data that suggests that exposure of T-cells to IL-7 may expand T-cells, prevent T-cell exhaustion, and improve effector functions. NT-I7 is a long-acting human IL-7 cytokine which has been shown in nonclinical studies to increase peripheral T-cells, antitumor efficacy, and tumor infiltrating lymphocytes, either as a monotherapy or in combination with chemo/radiotherapy and/or immune checkpoint inhibitors and CAR T therapy. This study is testing the hypothesis that the administration of NT-I7 following standard of care (SOC) approved CD19 CAR T-cell therapies for subjects with relapsed/refractory large B-cell lymphoma (LBCL) will be safe and tolerable and may increase the expansion and persistence of CAR T-cells in vivo, which may result in increased tumor response rate and improved clinical outcomes.

Key Dates

Start date
Mar 12, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Dose Level 1 Starting Dose: NT-I7
    NT-I7 will be administered as an intramuscular injection at 600 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections.
  • Experimental: Dose Escalation Dose Level 2: NT-I7
    NT-I7 will be administered as an intramuscular injection at 720 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections.
  • Experimental: Dose Expansion (RP2D): NT-I7
    NT-I7 will be administered as an intramuscular injection at the recommended phase 2 dose on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: From start of CAR T-cell infusion (day 0) through day 90 (post CAR T-cell infusion) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Zachary D Crees, M.D.
[email protected]
314-273-1039
Zachary D Crees, M.D. (PRINCIPAL_INVESTIGATOR)
John F DiPersio, M.D., Ph.D. (SUB_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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