Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ Confirmed diagnosis of multiple myeloma per IMWG criteria.
- ✓ Patient must be in first CR (including CR or sCR) or have PR or VGPR per IMWG criteria.
- ✓ Patient must be candidate for melphalan and AHCT in the opinion of the treating physician.
- ✓ At least 18 years of age.
- ✓ ECOG performance status ≤ 2
- ✓ Adequate bone marrow and organ function as defined below:
- ✓ Total bilirubin ≤ 2 x IULN
- ✓ AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
You may not qualify if…
- ✕ High doses of corticosteroids (greater than 5 mg prednisone equivalent daily) within 2 weeks of Day -2, with exception of premedication as needed for mobilization regimen.
- ✕ A history of T-cell malignancy, plasma cell leukemia, or amyloidosis, or history of any other malignancy with the exceptions of in situ carcinomas, non-melanoma skin cancers, and malignancies for which all treatment was completed at least 2 years before Day -2 and the patient has no evidence of disease.
- ✕ Currently receiving any other investigational agents.
- ✕ A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CYT107, melphalan, or other agents used in the study.
- ✕ Azathioprine, methotrexate, and anti-tumor necrosis factor agents within 2 weeks of Day -2.
- ✕ A history of congenital immunodeficiency syndrome or autoimmune disease. Patients with autoimmune disorders adequately controlled with medication (5 mg prednisone equivalent or less) are allowed.
- ✕ A history of clinically-significant pulmonary disorders, such as severe asthma, severe COPD, restrictive lung disease, pulmonary embolism within 3 months prior to study enrollment, or active or prior interstitial lung disease/pneumonitis.
- ✕ Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Where it's recruiting
St Louis
Source: ClinicalTrials.gov · NCT06523699 · last updated 2025-08-28