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

NCT07200089 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 202601207
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Keywords

Cytokines; Interleukin-7; Cellular therapy; Chimeric antigen receptor T cell therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

  At Day 100

• Progression-free survival (PFS)

  At Day 365

• Number of participants with Grade ≥2 CRS and ICANS according to ASTCT consensus grading

  From Day 0 through Day 100

Study Arms (5)

Dose Escalation Dose Level -1: NT-I7

EXPERIMENTAL

Patients will receive 480 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.

Drug: NT-I7

Dose Escalation Dose Level 1 (Starting Dose): NT-I7

EXPERIMENTAL

Patients will receive 600 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.

Drug: NT-I7

Dose Escalation Dose Level 2: NT-I7

EXPERIMENTAL

Patients will receive 720 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35.

Drug: NT-I7

Dose Expansion: NT-I7

EXPERIMENTAL

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

Dose Expansion: Placebo

SHAM COMPARATOR

Patients randomized to the control arm will receive a placebo on Days 14 and 35.

Drug: Placebo

Interventions

Placebo DRUG

Placebo will be supplied by NeoImmuneTech Inc

Dose Expansion: Placebo

NT-I7 DRUG

NT-I7 will be supplied by NeoImmuneTech Inc

Also known as: Recombinant human IL-7, Efineptakin alfa

Dose Escalation Dose Level -1: NT-I7; Dose Escalation Dose Level 1 (Starting Dose): NT-I7; Dose Escalation Dose Level 2: NT-I7; Dose Expansion: NT-I7

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• NeoImmuneTech: collaborator
• Swim Across America: 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

Interventions

efineptakin alfa

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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

Study Officials

• Michael Slade, M.D., M.S.C.I

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Slade, M.D., M.S.C.I.

CONTACT

314-454-8304; sladem@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential for the dose-escalation portion and parallel for the dose expansion portion.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Up to 5 years following trial completion.
• 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.

Locations

US (1)