Multiple MyelomaPhase 1NCT07200089
Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)
A Phase 1 study testing NT-I7 in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
- What is being tested?
- NT-I7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2026to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Michael Slade, M.D., M.S.C.I, 314-454-8304, sladem@wustl.edu
Michael Slade, M.D., M.S.C.I
About this study
Official title: 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.
- Being tested
- NT-I7, Placebo
- Keywords
- Cytokines, Interleukin-7, Cellular therapy, Chimeric antigen receptor T cell therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-I7Drug
Also called Recombinant human IL-7, Efineptakin alfa
NT-I7 will be supplied by NeoImmuneTech Inc
PlaceboDrug
Placebo will be supplied by NeoImmuneTech Inc
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: NT-I7 |
| Dose Expansion: Placebo | Sham comparator | Patients randomized to the control arm will receive a placebo on Days 14 and 35. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-hematologic grade ≥3 treatment-related adverse events (excluding expected conditioning-related AEs)
Graded per CTCAE v 5.0.
Measured: 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.
Measured: 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)
Measured: At Day 100
MRD negativity by clonoSEQ (10^6 cutoff)
Measured: 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 below
- Normal 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 aspirate
- Disappearance of any soft tissue plasmacytomas
- Normalization of the serum free light chain ratio in patients who lack measurable M protein in the serum and urine at baseline
Measured: 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.
Measured: At Day 365
Number of participants with Grade ≥2 CRS and ICANS according to ASTCT consensus grading
Measured: From Day 0 through Day 100
Number of participants with Grade ≥3 CRS and ICANS according to ASTCT consensus grading
Measured: 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.
Measured: By Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start5 Jun 2026
- Primary completion10 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential for the dose-escalation portion and parallel for the dose expansion portion.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- NeoImmuneTech, Swim Across America
- Responsible party
- Sponsor
- Investigators
- Michael Slade, M.D., M.S.C.I, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200089
- Sponsor's protocol ID
- 202601207
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient level data may be shared following publication of the manuscript analyzing the primary endpoint of this study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07200089
- Acronym / sponsor ID
- 202601207
- Keywords
- Cytokines, Interleukin-7, Cellular therapy, Chimeric antigen receptor T cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- NeoImmuneTech, Swim Across America
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 10 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- Sequential for the dose-escalation portion and parallel for the dose expansion portion.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Dose Level -1: NT-I7 | Experimental | Drug: NT-I7Patients will receive 480 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35. |
| Dose Escalation Dose Level 1 (Starting Dose): NT-I7 | Experimental | Drug: NT-I7Patients will receive 600 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35. |
| Dose Escalation Dose Level 2: NT-I7 | Experimental | Drug: NT-I7Patients will receive 720 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35. |
| Dose Expansion: NT-I7 | Experimental | Drug: NT-I7Patients 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. |
| Dose Expansion: Placebo | Sham comparator | Drug: PlaceboPatients randomized to the control arm will receive a placebo on Days 14 and 35. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- Life expectancy ≥ 12 weeks per assessment from the enrolling physician.
- At least 18 years of age.
- ECOG performance status ≤ 2
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-I7Also: Recombinant human IL-7, Efineptakin alfaNT-I7 will be supplied by NeoImmuneTech Inc | Drug | 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 |
| PlaceboPlacebo will be supplied by NeoImmuneTech Inc | Drug | Dose Expansion: Placebo |
Primary outcome
Rate of non-hematologic grade ≥3 treatment-related adverse events (excluding expected conditioning-related AEs)
Time frame: From Day 14 to Day 100
Graded per CTCAE v 5.0.
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)
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.
7 secondary outcomes
MRD negativity by clonoSEQ (10^5 cutoff)
Time frame: At Day 100
MRD negativity by clonoSEQ (10^6 cutoff)
Time frame: At Day 100
Number of participants with stringent complete response (sCR) by IMWG criteria
Time frame: At Day 100
Progression-free survival (PFS)
Time frame: At Day 365
Number of participants with Grade ≥2 CRS and ICANS according to ASTCT consensus grading
Time frame: From Day 0 through Day 100
Number of participants with Grade ≥3 CRS and ICANS according to ASTCT consensus grading
Time frame: From Day 0 through Day 100
Rate of non-relapse mortality (NRM)
Time frame: By Day 365
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified patient level data may be shared following publication of the manuscript analyzing the primary endpoint of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Slade, M.D., M.S.C.I principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NT-I7 in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Slade, M.D., M.S.C.I. (314-454-8304, sladem@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.