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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Recombinant glycosylated human interleukin-7; Drug: Melphalan; Procedure: Autologous hematopoietic cell transplant

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dilan A Patel, M.D.; Phone Number: 314-747-8173; Email: dpatel1@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Richard Hotchkiss, M.D.
      • Sub-Investigator: John F DiPersio, M.D., Ph.D.
      • Sub-Investigator: Feng Gao, Ph.D.
      • Contact: Dilan A Patel, M.D.; Phone Number: 314-747-8173; Email: dpatel1@wustl.edu
      • Principal Investigator: Dilan Patel, M.D.
      • Sub-Investigator: Michael Bern, M.D., Ph.D.
      • Sub-Investigator: Erik Dubberke, M.D.
      • Sub-Investigator: Chris Farnsworth, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
  • Creatinine clearance ≥ 30 mL/min by Cockcroft-Gault
• The effects of CYT107 on the developing human fetus are unknown. For this reason and also because many alkylating agents such as melphalan are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for one year post-transplant. Should a woman become pregnant or suspect she is pregnant, or a male suspect he has fathered a child during this time frame, s/he must inform the treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• 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.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day -2.
• Patients without a backup autologous stem cell graft available.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Recombinant glycosylated human interleukin-7; Provided by RevImmune; Other Names: CYT107; r-hIL-7; Drug: Melphalan; Standard of care; Procedure: Autologous hematopoietic cell transplant; Standard of care; Other Names: AHCT
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).	Drug: Melphalan; Standard of care; Procedure: Autologous hematopoietic cell transplant; Standard of care; Other Names: AHCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Treatment-related AEs will be defined as AEs occurring that are at least possibly related to the CYT107 treatment, or the combination of melphalan, AHCT, and CYT107.	Through day 365

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of minimal residual disease (MRD)	For the purposes of this study, a patient will be considered as having minimal residual diseases if a positive result (per 10-5 threshold) is obtained using the Adaptive Clonoseq MRD testing.	At Day 100
Rate of response by IMWG of ≥ complete response (CR)	Stringent complete response (sCR):CR as defined belowNormal free light chain ratio (0.26-1.65)Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence; Complete response (CR):Negative immunofixation on the serum and urine<5% plasma cells in the bone marrow aspirateDisappearance of any soft tissue plasmacytomas	At Day 100
Rate of ≥ grade 3 infections		Through day 365
Days from transplant until absolute neutrophil count (ANC) engraftment	Neutrophil engraftment is defined as the first day of 3 consecutive days of ANC ≥ 500 following the post-transplant nadir.	Through Day 30
Feasibility of treatment schedule	The study will be feasible if 20% of patients are able to receive all 5 doses of CYT107 within the first month post-transplant.	1 month post-transplant (transplant is on Day 0)
Absolute lymphocyte count (ALC) recovery from pre-AHCT		Through Day 30

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Revimmune
• Investigators: Principal Investigator: Dilan A Patel, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Autologous; Cytokine; Transplant; Myeloma; Immune reconstitution; IL-7
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Neoplasms, Plasma Cell; Amino Acids, Peptides, and Proteins; Organic Chemicals; Hydrocarbons; Amino Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Melphalan
• Other Study ID Numbers: 202412127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No