Interleukin-7 for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Dilan A Patel, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: Corticosteroids, Azathioprine, Methotrexate, others

Disqualifiers: T-cell malignancy, Plasma cell leukemia, Amyloidosis, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for multiple myeloma, a type of blood cancer. Researchers aim to determine if adding CYT107, a form of interleukin-7, after a stem cell transplant can enhance immune system recovery and improve its ability to fight cancer cells. Participants will receive either the new treatment plus standard care or just the standard care. The trial seeks individuals with multiple myeloma who are currently undergoing or are candidates for a stem cell transplant. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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

The trial requires that you stop taking high doses of corticosteroids and certain medications like azathioprine, methotrexate, and anti-tumor necrosis factor agents at least 2 weeks before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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

Research has shown that a treatment called recombinant human Interleukin-7 (CYT107) has shown promise in earlier studies. In one study, patients with various types of cancer received CYT107, and it was generally safe. Most patients tolerated the treatment well, with no serious side effects. Another study with lymphoma patients found that CYT107 helped increase immune cell numbers and was also well-tolerated.

While these results are encouraging, the current study remains in its early stages. This phase focuses on assessing safety, so monitoring for any side effects is a priority, even though evidence suggests CYT107 could be safe. It is crucial to discuss potential risks and benefits with healthcare providers before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatment for multiple myeloma, which typically includes drugs like melphalan and stem cell transplants, CYT107 introduces a unique approach by using recombinant human Interleukin-7. Most treatments focus on directly attacking cancer cells, but CYT107 works differently by enhancing the immune system's ability to fight the cancer. This new mechanism of action could potentially improve patient outcomes by boosting immune function, offering a fresh angle in the fight against this challenging disease. Researchers are excited because CYT107 might complement existing therapies, making the overall treatment more effective.

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

Research has shown that recombinant human Interleukin-7 (CYT107) might benefit people with multiple myeloma. In this trial, participants in the experimental arm will receive CYT107 after a transplant. Studies have found that administering IL-7 post-transplant can aid in the recovery of crucial immune cells called T-cells. These cells play a vital role in combating infections and cancer. This immune system boost has been linked to longer tumor-free periods. In animal studies, a similar IL-7 treatment reduced tumor size and extended lifespan. These findings suggest that CYT107 could help reduce tumors and strengthen the immune system in people with multiple myeloma. ^{1 2 4 5 6}

Who Is on the Research Team?

Dilan A Patel, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for multiple myeloma patients who are undergoing autologous hematopoietic cell transplant. Participants must meet certain health standards, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I can understand and am willing to sign a consent form.

I can take care of myself but might not be able to do heavy physical work.

My doctor thinks I am a good candidate for melphalan and stem cell transplant.

Exclusion Criteria

I haven't taken high doses of steroids in the last 2 weeks.

I am allergic to medications similar to CYT107, melphalan, or others in the study.

Currently receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT). In the experimental arm, CYT107 is administered subcutaneously starting on Day 1, with two doses in the first week and weekly for 3 more weeks.

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for minimal residual disease and response rates.

100 days

Long-term follow-up

Monitoring for non-hematologic grade ≥3 CYT107 treatment-related adverse events.

365 days

What Are the Treatments Tested in This Trial?

Interventions

• Recombinant Human Interleukin-7 (CYT107)

Trial Overview The study compares two groups: one receiving standard care with melphalan and a stem cell transplant, and the other adding CYT107 to this regimen. The goal is to see if CYT107 improves immune system recovery and helps clear cancer cells more effectively.

How Is the Trial Designed?

Group I: CYT107 + Melphalan + AHCT Experimental Treatment 3 Interventions

All patients on this protocol will be treated with standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT). After AHCT, if patients are randomized to the experimental arm, CYT107 will be initiated and will continue for 4 weeks. CYT107 will be administered subcutaneously starting on D+1. Two doses will be given during the first week, and then CYT107 will be administered weekly for 3 more weeks for a total of 5 doses.

Group II: Melphalan + AHCT Active Control 2 Interventions

All patients on this protocol will be treated with standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Revimmune

Industry Sponsor

Trials

11

Recruited

210+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06523699?cond=Cancer&aggFilters=funderType%3Aindustry%2CstudyType%3Aint

NCT06523699 | Impact of Recombinant Human Interleukin ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2808195/

Phase I study of recombinant human interleukin-7 ... IL-7 administration post-transplant results both in improved T-cell recovery and in prolonged tumor free survival (12). Immune enhancement after severe immune ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2473952923003762

Anti-myeloma efficacy of CAR-iNKT is enhanced with a ... We found that a long-acting interleukin-7 (IL-7), rhIL-7-hyFc, significantly prolonged survival and reduced tumor burden in BCMA CAR-iNKT–treated mice.

4. withpower.com withpower.com/trial/phase-1-neoplasms-plasma-cell-9-2024-6fe63

Interleukin-7 for Multiple Myeloma Participants are monitored for safety and effectiveness after treatment, including assessments for minimal residual disease and response rates. 100 days. Long- ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/16/2/727/75934/Phase-I-Study-of-Recombinant-Human-Interleukin-7

Phase I Study of Recombinant Human Interleukin-7 ... IL-7 administration post-transplant results in both improved T-cell recovery and prolonged tumor-free survival (12). Immune enhancement after ...

6. 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 ...