NT-I7 for Relapsed/Refractory Multiple Myeloma After CAR-T Therapy
This study is looking at a drug called NT-I7 for people with multiple myeloma (a type of blood cancer) that has come back or is not responding to treatment, especially after receiving BCMA CAR-T cell therapy (a treatment where your own immune cells are modified to fight cancer). While CAR-T therapy can be very effective, its benefits don't always last. NT-I7 is being studied to see if it can help CAR-T cells work better and for longer. You might be eligible if you have multiple myeloma that can be measured and you are able to receive standard BCMA CAR-T cell therapy. The study aims to understand the safety of NT-I7 and find the right dose. This study is currently recruiting about 52 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It involves comparing NT-I7 to a placebo (an inactive substance) and plans to enroll 52 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety is measured from Day 14 to Day 100. The recommended dose is determined through day 65 for some participants.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07200089
Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~52 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:NT-I7Placebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of non-hematologic grade ≥3 treatment-related adverse events (excluding expected conditioning-related AEs)
Measured over From Day 14 to Day 100
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Michael Slade, M.D., M.S.C.I · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Rate of non-hematologic grade ≥3 treatment-related adverse events (excluding expected conditioning-related AEs)From Day 14 to Day 100
Graded per CTCAE v 5.0.
- Recommended phase II dose (Dose escalation stage only)Through day 65 for all dose escalation stage patients (estimated to be 3 months and 65 days)
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.