Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07200089
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • NT-I7 — DRUG
    NT-I7 will be supplied by NeoImmuneTech Inc
  • Placebo — DRUG
    Placebo will be supplied by NeoImmuneTech Inc

Study Details

CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown. This is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.

Key Dates

Start date
Jun 5, 2026
Status verified
Jun 2026
Primary completion
Mar 10, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Dose Level -1: NT-I7
    Patients will receive 480 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.
  • Experimental: Dose Escalation Dose Level 1 (Starting Dose): NT-I7
    Patients will receive 600 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.
  • Experimental: Dose Escalation Dose Level 2: NT-I7
    Patients will receive 720 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.
  • Experimental: Dose Expansion: NT-I7
    Patients randomized to the intervention arm will receive the recommended phase II dose of NT-I7 intramuscularly on Day 14 and a second dose on Day 35.
  • Sham Comparator: Dose Expansion: Placebo
    Patients randomized to the control arm will receive a placebo on Days 14 and 35.

Primary Outcome Measure

Rate of non-hematologic grade ≥3 treatment-related adverse events (excluding expected conditioning-related AEs) [ Time Frame: From Day 14 to Day 100 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Michael Slade, M.D., M.S.C.I
[email protected]
314-454-8304
Michael Slade, M.D., M.S.C.I (PRINCIPAL_INVESTIGATOR)
Arun Cumpelik, M.D. (SUB_INVESTIGATOR)
John F DiPersio, M.D., Ph.D. (SUB_INVESTIGATOR)
Feng Gao, M.D., Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Washington University School of Medicine· St Louis, MO

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