Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)

A Double-blind, Placebo-controlled Phase Ib Study Evaluating the Safety and Toxicity of Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)

CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown.

This is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory
• Intervention / Treatment: Drug: Placebo; Drug: NT-I7

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Slade, M.D., M.S.C.I.; Phone Number: 314-454-8304; Email: sladem@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Feng Gao, M.D., Ph.D.
      • Sub-Investigator: John F DiPersio, M.D., Ph.D.
      • Contact: Michael Slade, M.D., M.S.C.I; Phone Number: 314-454-8304; Email: sladem@wustl.edu
      • Principal Investigator: Michael Slade, M.D., M.S.C.I
      • Sub-Investigator: Arun Cumpelik, M.D.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of multiple myeloma with measurable disease by IMWG criteria.

• Eligible for standard of care, FDA-approved BCMA CAR-T cell therapy with ciltacabtagene autoleucel.

  • Patients enrolling in the dose escalation stage must have received at least two prior lines of treatment and be penta-drug exposed (i.e. exposure to at least 5 active anti-myeloma drugs, excluding corticosteroids and melphalan and including, at minimum, a proteasome inhibitor, an immunomodulatory drug, and a CD38 monoclonal antibody).
• Life expectancy ≥ 12 weeks per assessment from the enrolling physician.
• At least 18 years of age.
• ECOG performance status ≤ 2

• Adequate organ function as defined below:

  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
• The effects of NT-I7 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry until 90 days after completion of NT-I7 therapy/placebo (corresponding to Day 125 post CAR-T). Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

• Received prior BCMA-directed therapy.
• Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
• Currently receiving or have received any other investigational agents within 14 days prior to CAR-T infusion.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to NT-I7or other agents used in the study.
• Uncontrolled intercurrent illness including but not limited to: ongoing or active infection (bacterial, fungal, viral, or tuberculosis, including known hepatitis A, B, or C, or HIV (testing not required)), symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia (except well-controlled atrial fibrillation). Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting CAR-T therapy.
• Receipt of live, attenuated vaccine within 30 days prior to first day of treatment.
• Had an allogeneic tissue/solid organ transplant or allogeneic stem cell transplant.
• Not able to receive intramuscular therapy.
• Prior history of T cell malignancy.
• Prior history of congenital immunodeficiency syndrome.
• Prior history of autoimmune disease with significant disease activity in the past 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sézary syndrome, vasculitis or glomerulonephritis, Bell's palsy, Guillain-Barré syndrome, or multiple sclerosis.
• Prior history of plasma cell leukemia, systemic amyloidosis, POEMS syndrome, or multiple myeloma with CNS involvement.
• Planning to start maintenance therapy prior to Day 100 post-CAR-T therapy.
• A history of clinically significant pulmonary disorders, such as severe asthma, severe COPD, restrictive lung disease, symptomatic pulmonary embolism within 3 months prior to study enrollment, or active or prior interstitial lung disease/pneumonitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Dose Level -1: NT-I7; Patients will receive 480 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.	Drug: NT-I7; NT-I7 will be supplied by NeoImmuneTech Inc; Other Names: Efineptakin alfa; Recombinant human IL-7
Experimental: Dose Escalation Dose Level 1 (Starting Dose): NT-I7; Patients will receive 600 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.	Drug: NT-I7; NT-I7 will be supplied by NeoImmuneTech Inc; Other Names: Efineptakin alfa; Recombinant human IL-7
Experimental: Dose Escalation Dose Level 2: NT-I7; Patients will receive 720 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.	Drug: NT-I7; NT-I7 will be supplied by NeoImmuneTech Inc; Other Names: Efineptakin alfa; Recombinant human IL-7
Experimental: Dose Expansion: NT-I7; Patients randomized to the intervention arm will receive the recommended phase II dose of NT-I7 intramuscularly on Day 14 and a second dose on Day 35.	Drug: NT-I7; NT-I7 will be supplied by NeoImmuneTech Inc; Other Names: Efineptakin alfa; Recombinant human IL-7
Sham Comparator: Dose Expansion: Placebo; Patients randomized to the control arm will receive a placebo on Days 14 and 35.	Drug: Placebo; Placebo will be supplied by NeoImmuneTech Inc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of non-hematologic grade ≥3 treatment-related adverse events (excluding expected conditioning-related AEs)	Graded per CTCAE v 5.0.	From Day 14 to Day 100
Recommended phase II dose (Dose escalation stage only)	The recommended phase II dose (RP2D) is defined as the highest tested dose level or the dose level immediately below the dose level at which 2 or more patients experience dose-limiting toxicity during the dose-limiting toxicity (DLT) assessment period.	Through day 65 for all dose escalation stage patients (estimated to be 3 months and 65 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRD negativity by clonoSEQ (10^5 cutoff)		At Day 100
MRD negativity by clonoSEQ (10^6 cutoff)		At Day 100
Number of participants with stringent complete response (sCR) by IMWG criteria	Stringent complete response requires all of the following: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) requires all of the following:Negative immunofixation on the serum and urine<5% plasma cells in the bone marrow aspirateDisappearance of any soft tissue plasmacytomasNormalization of the serum free light chain ratio in patients who lack measurable M protein in the serum and urine at baseline	At Day 100
Progression-free survival (PFS)	PFS is defined as the length of time between randomization and disease progression or death from any cause.; Progressive disease per IMWG criteria.	At Day 365
Number of participants with Grade ≥2 CRS and ICANS according to ASTCT consensus grading		From Day 0 through Day 100
Number of participants with Grade ≥3 CRS and ICANS according to ASTCT consensus grading		From Day 0 through Day 100
Rate of non-relapse mortality (NRM)	For the purposes of this study, NRM is death following CAR-T cell infusion without evidence of progressive myeloma.	By Day 365

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Swim Across America; NeoImmuneTech
• Investigators: Principal Investigator: Michael Slade, M.D., M.S.C.I, 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): June 5, 2026
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: September 22, 2025
• First Posted (Actual): September 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cytokines; Cellular therapy; Interleukin-7; Chimeric antigen receptor T cell therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Amino Acids, Peptides, and Proteins; Proteins; Receptors, Cell Surface; Membrane Proteins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; efineptakin alfa
• Other Study ID Numbers: 202601207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified patient level data may be shared following publication of the manuscript analyzing the primary endpoint of this study.
• IPD Sharing Time Frame: Up to 5 years following trial completion.
• IPD Sharing Access Criteria: Interested researchers seeking access to de-identified data related to this trial should contact the principal investigator at sladem@wustl.edu. Requests will be considered on a case-by-case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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