Recruiting
Phase 1

BCMA CAR-T with NT-I7

Sponsor:

Washington University School of Medicine

Code:

NCT07200089

Conditions

Multiple Myeloma

Multiple Myeloma in Relapse

Multiple Myeloma, Refractory

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NT-I7

Placebo

Study Details

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

Study ID

NCT07200089

Start date

Aug 31, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Mar 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

sham comparator: Dose Expansion: Placebo

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

Interventions

NT-I7

NT-I7 will be supplied by NeoImmuneTech Inc

Placebo

Placebo will be supplied by NeoImmuneTech Inc

Primary outcome measure

  • Rate of non-hematologic grade ≥3 treatment-related adverse events (excluding expected conditioning-related AEs) [ Time Frame: From Day 14 to Day 100 ]
  • Recommended phase II dose (Dose escalation stage only) [ Time Frame: Through day 65 for all dose escalation stage patients (estimated to be 3 months and 65 days) ]

Central Contacts and Locations

Central contacts

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

314-454-8304sladem@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

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

314-454-8304sladem@wustl.edu

Principal Investigator:

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

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-21.