NT-I7 + CAR-T Therapy for Multiple Myeloma

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must be taking: BCMA CAR-T

Must not be taking: Investigational agents

Disqualifiers: Prior BCMA therapy, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment for multiple myeloma, a type of blood cancer, by combining two therapies. It tests whether adding NT-I7, an experimental treatment, to CAR-T cell therapy can enhance the body's ability to fight cancer more effectively and for a longer period. Participants will receive either the NT-I7 treatment or a placebo for comparison. This trial targets individuals with multiple myeloma who qualify for standard CAR-T therapy and have not previously received similar treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents within 14 days before the CAR-T infusion.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NT-I7 has been safe and well-tolerated in earlier studies. For example, NT-I7 increased T-cell counts in healthy individuals without major safety issues. In patients with lymphoma, NT-I7 safely promoted the growth of CAR-T cells. This suggests that NT-I7 might complement CAR-T therapy for multiple myeloma, although its effects in this specific context remain unknown.

CAR-T therapy itself carries risks. It may cause side effects because it modifies T-cells to combat cancer. However, these treatments are already used for some cancers, indicating they are considered safe enough to try in certain cases.

Overall, NT-I7 appears to have a good safety record, but its effects on multiple myeloma patients are still under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NT-I7 for multiple myeloma because it works differently from standard treatments like chemotherapy and proteasome inhibitors. NT-I7 is an innovative agent that boosts the immune system by enhancing T-cell activity, which is crucial for fighting cancer cells. Unlike traditional therapies, which often target cancer cells directly, NT-I7 supports the body's natural defenses, potentially leading to fewer side effects and improved patient outcomes. This novel approach could complement existing CAR-T therapies, offering a promising new avenue for patients with multiple myeloma.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that NT-I7 can enhance the effectiveness of CAR-T cell therapy. In individuals with lymphoma, NT-I7 promotes the growth of CAR-T cells, increasing the treatment's effectiveness while maintaining safety. Studies with mice have demonstrated promising results when combining NT-I7 with CAR-T therapy, suggesting it could enhance the body's ability to fight cancer. In this trial, participants in the intervention arm will receive NT-I7 alongside CAR-T therapy, with the hope that NT-I7 will prolong the activity of CAR-T cells and improve their effectiveness against multiple myeloma. Participants in the control arm will receive a placebo. CAR-T therapy, particularly for multiple myeloma, often shows initial success, but its effects tend to diminish over time. ^{1 2 4 6 7}

Who Is on the Research Team?

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

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with multiple myeloma who have not responded to or have relapsed after BCMA CAR-T therapy. Participants must meet certain health standards, which are not specified here.

Inclusion Criteria

Ability to understand and willingness to sign an IRB approved written informed consent document

Life expectancy ≥ 12 weeks per assessment from the enrolling physician

Agree to use adequate contraception if of childbearing potential

Exclusion Criteria

Currently receiving or have received any other investigational agents within 14 days prior to CAR-T infusion

History of allergic reactions to compounds of similar composition to NT-I7 or other study agents

Pregnant and/or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BCMA CAR-T therapy followed by either NT-I7 or placebo on Days 14 and 35

14 weeks

2 visits (in-person) for NT-I7 or placebo administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

From Day 14 to Day 100

Long-term Follow-up

Participants are monitored for progression-free survival and non-relapse mortality

Up to Day 365

What Are the Treatments Tested in This Trial?

Interventions

• NT-I7

Trial Overview The study tests the safety and effectiveness of adding NT-I7 to standard BCMA CAR-T therapy in enhancing T-cell expansion and persistence for better treatment outcomes in a randomized, placebo-controlled setting.

How Is the Trial Designed?

Group I: Intervention: NT-I7 Experimental Treatment 0 Interventions

Patients randomized to the intervention arm will receive 720 μg/kg NT-I7 intramuscularly on Day 14 and a second dose on Day 35 after BCMA CAR-T infusion.

Group II: Control: Placebo Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

NeoImmuneTech

Industry Sponsor

Trials

16

Recruited

780+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268061/

rhIL-7-hyFc, a long-acting interleukin-7, improves efficacy of ... This study provides a rationale for NT-I7 plus CAR-T cell combination therapy for solid tumors in humans.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07200089

Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory ... 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 ...

3. academic.oup.com academic.oup.com/noa/article/7/1/vdaf117/8158267

Phase I study of NT-I7, a long-acting interleukin-7, in severe ... In addition, the use of NT-I7 with chimeric antigen receptor T-cell (CAR-T) therapy has demonstrated promising results in mouse models.24 ...

4. nature.com nature.com/articles/s41392-025-02269-w

CAR-T cell therapy for cancer: current challenges and ... Among those patients who received the recommended dose, the 3-year overall survival and event-free survival were 60% and 36%, respectively. The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925001558

CAR-T cell therapy for patients with extramedullary multiple ... CAR-T improved overall patient outcomes, but EMD patients still had significantly worse outcomes. Dima D, et al. [35] analyzed data on MM ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12112896/

Toxicity of CAR T-Cell Therapy for Multiple Myeloma - PMC CAR-T therapy theoretically poses a risk for hematologic malignancies like myelodysplastic syndrome (MDS) due to potential adverse gene integration events or ...

7. withpower.com withpower.com/trial/phase-1-multiple-myeloma-2026-aeaa4

NT-I7 + CAR-T Therapy for Multiple Myeloma ... 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-arm ...