RecruitingPhase 1NCT06523699

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

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


Sponsor

Washington University School of Medicine

Enrollment

30 participants

Start Date

Apr 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called CYT107 (recombinant human interleukin-7) can help multiple myeloma patients rebuild their immune system more effectively after a stem cell transplant using their own cells (autologous transplant). Researchers hope that boosting immune recovery after transplant may help the body clear any remaining cancer cells. **You may be eligible if...** - You are 18 or older with confirmed multiple myeloma - Your myeloma is in complete remission or has responded well to treatment (CR, sCR, PR, or VGPR) - Your doctor considers you a good candidate for an autologous stem cell transplant using melphalan conditioning - Your organ function (liver, kidneys, bone marrow) meets required thresholds - You have a backup stem cell graft available **You may NOT be eligible if...** - You are currently taking high-dose steroids (above 5 mg prednisone equivalent daily) - You have a history of T-cell cancer, plasma cell leukemia, or amyloidosis - You are enrolled in another investigational drug study - You have significant lung disease such as severe asthma, COPD, or recent pulmonary embolism - You have uncontrolled infections, heart failure, or unstable heart conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant glycosylated human interleukin-7

Provided by RevImmune

DRUGMelphalan

Standard of care

PROCEDUREAutologous hematopoietic cell transplant

Standard of care


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06523699


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