Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06523699
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Recombinant glycosylated human interleukin-7 — DRUG
    Provided by RevImmune
  • Melphalan — DRUG
    Standard of care
  • Autologous hematopoietic cell transplant — PROCEDURE
    Standard of care

Study Details

This is a two-arm, open-label, randomized, single-site, pilot study testing the addition of CYT107 following autologous hematopoietic cell transplant (AHCT) in patients with multiple myeloma (MM). The hypothesis of this study is that recombinant human CYT107 can be safely administered after AHCT and will promote quantitative and qualitative T cell reconstitution, which will be associated with enhanced tumor cell clearance and reduced infectious complications. Patients will be randomized to either the intervention arm that will receive CYT107 + standard of care melphalan and AHCT or to the control arm that will receive standard of care melphalan and AHCT only.

Key Dates

Start date
Apr 4, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CYT107 + Melphalan + AHCT
    All patients on this protocol will be treated with standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT). After AHCT, if patients are randomized to the experimental arm, CYT107 will be initiated and will continue for 4 weeks. CYT107 will be administered subcutaneously starting on D+1. Two doses will be given during the first week, and then CYT107 will be administered weekly for 3 more weeks for a total of 5 doses.
  • Active Comparator: Melphalan + AHCT
    All patients on this protocol will be treated with standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT).

Primary Outcome Measure

Rate of non-hematologic grade ≥3 CYT107 treatment-related AEs (excluding expected transplant-related AEs or AEs attributed to melphalan and ASCT) according to CTCAE v5 [ Time Frame: Through day 365 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Dilan A Patel, M.D.
[email protected]
314-747-8173
Dilan Patel, M.D. (PRINCIPAL_INVESTIGATOR)
Michael Bern, M.D., Ph.D. (SUB_INVESTIGATOR)
John F Dipersio, M.D., Ph.D. (SUB_INVESTIGATOR)
Richard Hotchkiss, M.D. (SUB_INVESTIGATOR)
Erik Dubberke, M.D. (SUB_INVESTIGATOR)
Chris Farnsworth, Ph.D. (SUB_INVESTIGATOR)
Feng Gao, 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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