Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)

NCT ID: NCT07200089

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-07-31

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-arm, double blind, placebo-controlled, randomized, single-site phase Ib study 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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention: NT-I7

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 Type: EXPERIMENTAL

No interventions assigned to this group

Control: Placebo

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

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be supplied by NeoImmuneTech Inc

B-cell Maturation Antigen (BCMA) CART-T therapy

Intervention Type: BIOLOGICAL

Standard of care

Interventions

NT-I7

NT-I7 will be supplied by NeoImmuneTech Inc

Intervention Type: DRUG

Placebo

Placebo will be supplied by NeoImmuneTech Inc

Intervention Type: DRUG

B-cell Maturation Antigen (BCMA) CART-T therapy

Standard of care

Intervention Type: BIOLOGICAL

Other Intervention Names

Recombinant human IL-7

Eligibility Criteria

Inclusion Criteria

• Diagnosis of multiple myeloma with measurable disease by IMWG criteria.
• Eligible for standard of care BCMA CAR-T cell therapy.
• 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 subcutaneous 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeoImmuneTech

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Central Contacts

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

Role: CONTACT

Phone: 314-454-8304

Email: sladem@wustl.edu

Facility Contacts

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

Role: primary

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

25-x122

Identifier Type: -

Identifier Source: org_study_id