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

NCT06523699 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 202412127
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Myeloma; Immune reconstitution; IL-7; Cytokine; Autologous; Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of minimal residual disease (MRD)

  At Day 100

• Rate of response by IMWG of ≥ complete response (CR)

  At Day 100

• Rate of ≥ grade 3 infections

  Through day 365

• Days from transplant until absolute neutrophil count (ANC) engraftment

  Through Day 30

• Feasibility of treatment schedule

  1 month post-transplant (transplant is on Day 0)

Study Arms (2)

CYT107 + Melphalan + AHCT

EXPERIMENTAL

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; Drug: Melphalan; Procedure: Autologous hematopoietic cell transplant

Melphalan + AHCT

ACTIVE COMPARATOR

All patients on this protocol will be treated with standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT).

Drug: Melphalan; Procedure: Autologous hematopoietic cell transplant

Interventions

Recombinant glycosylated human interleukin-7 DRUG

Provided by RevImmune

Also known as: CYT107, r-hIL-7

CYT107 + Melphalan + AHCT

Melphalan DRUG

Standard of care

CYT107 + Melphalan + AHCT; Melphalan + AHCT

Autologous hematopoietic cell transplant PROCEDURE

Standard of care

Also known as: AHCT

CYT107 + Melphalan + AHCT; Melphalan + AHCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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).

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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Revimmune: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Dilan A Patel, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilan A Patel, M.D.

CONTACT

314-747-8173; dpatel1@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 2:1 to receive CYT107 + standard of care melphalan and AHCT or standard of care melphalan and AHCT alone.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: April 4, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)