Is NCT07200089 recruiting in St Louis, MO?

Yes, NCT07200089 is currently recruiting participants at its St Louis, MO location. This multiple myeloma clinical trial is actively enrolling qualified participants.

How do I join the multiple myeloma clinical trial in St Louis?

To join this clinical trial in St Louis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this St Louis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Multiple Myeloma Clinical Trial in St Louis, MO

About This Multiple Myeloma Study in St Louis

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.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

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 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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT07200089) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Myeloma Treatment Options in St Louis, MO

If you're searching for multiple myeloma treatment options in St Louis, MO, this clinical trial (NCT07200089) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple myeloma clinical trials near you to find additional studies recruiting in your area.

Multiple Myeloma Clinical Trial in St Louis, MO

Expert Care in St Louis

IRB Approved

No-Cost Care

Apply for This St Louis Location

Why Participate?

Simple Process