Is NCT07052305 recruiting in St Louis, MO?

Yes, NCT07052305 is currently recruiting participants at its St Louis, MO location. This large b-cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the large b-cell lymphoma 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.

Large B-cell Lymphoma Clinical Trial in St Louis, MO

About This Large B-cell Lymphoma Study in St Louis

Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed/refractory disease. CAR T-cell therapy has revolutionized modern cancer therapy, with axicabtagene ciloleucel and lisocabtagene maraleucel (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed/refractory large B-cell lymphoma. IL-7 plays a crucial role in T-cell homeostasis by inducing thymic differentiation, peripheral expansion, and extrathymic differentiation. It is the main regulator of T-cell hemostasis, inducing T-cell growth and proliferation in lymphopenic patients. There is data that suggests that exposure of T-cells to IL-7 may expand T-cells, prevent T-cell exhaustion, and improve effector functions. NT-I7 is a long-acting human IL-7 cytokine which has been shown in nonclinical studies to increase peripheral T-cells, antitumor efficacy, and tumor infiltrating lymphocytes, either as a monotherapy or in combination with chemo/radiotherapy and/or immune checkpoint inhibitors and CAR T therapy. This study is testing the hypothesis that the administration of NT-I7 following standard of care (SOC) approved CD19 CAR T-cell therapies for subjects with relapsed/refractory large B-cell lymphoma (LBCL) will be safe and tolerable and may increase the expansion and persistence of CAR T-cells in vivo, which may result in increased tumor response rate and improved clinical outcomes.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

Histologically confirmed relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, DLBCL arising from an indolent lymphoma, grade 3B follicular lymphoma and primary mediastinal large B-cell lymphoma.

Measurable disease by IWG response criteria for lymphoma.

Baseline FDG-PET/CT scan must show FDG-avid lesions compatible with CT-defined anatomical tumor sites.

A previously irradiated lesion can be considered a target lesion if it is well defined, measurable, and has clearly progressed following radiation.

FDG-PET/CT scans done as SOC up to 60 days pre-lymphodepletion therapy will be allowed. NOTE: After eligibility is confirmed, restaging FDG-PET/CT scans will not be used to change eligibility.

Eligible for treatment with an FDA-approved SOC CD19 CAR T-cell therapy respective to the current FDA-approved CAR T-cell label for axi-cel(Yescarta®) or liso-cel (Breyanzi®).

If the patient has previously received an autologous stem cell transplant, s/he must be at least 3 months post-transplant.

At least 18 years of age.

ECOG performance status ≤ 2

Adequate bone marrow and organ function at the start of lymphodepleting chemotherapy as pre-conditioning for SOC CD19 CAR T-cell infusion as defined below:

Absolute neutrophil count ≥ 1.0 K/cumm

Platelets ≥ 50 K/cumm

Hemoglobin ≥ 8.0 g/dL

Total bilirubin ≤ 1.5 x IULN or direct bilirubin ≤ IULN for patients with total bilirubin levels \> 1.5 x IULN (except for patients with Gilbert's syndrome, who must have a baseline total bilirubin ≤ 3.0 mg/dL)

AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (except for patients with documented liver involvement or bone metastases, who must have an AST and/or ALT ≤ 5.0 x IULN)

Alkaline phosphatase ≤ 2.5 x IULN (except for patients with liver metastasis, who must have an alkaline phosphatase ≤ 5.0 x IULN)

Creatinine clearance ≥ 30 mL/min by Cockcroft-Gault

INR and aPTT ≤ 1.5 x IULN unless the patient is receiving anticoagulant therapy and the PT or aPTT is within the therapeutic range for the anticoagulant. Patients who are on anticoagulation should be able to hold the anticoagulant for 4-5 half-lives of the anticoagulant prior to IM NT-I7 injection to reduce risk of hematoma.

ECG demonstrating Fridericia's corrected QT interval (QTcF) \< 500 ms; patients with QTcF ≥ 500 ms will require clearance by a cardiologist.

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, for the duration of study participation, and for 90 days after the last NT-I7 injection. 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

Previous receipt of an allogeneic solid organ transplant or bone marrow transplant.

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.

Chemotherapy or biologic or hormonal therapy for prior or concurrent cancer treatment, within 14 days prior to the first NT-I7 injection.

NOTE: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable.

Currently receiving any other investigational agents, or received within 14 days prior to the first NT-I7 injection.

Documented active central nervous system (CNS) involvement by lymphoma.

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to NT-I7 or other agents used in the study.

Presence of clinically significant, unresolved toxicities from prior anticancer therapy, defined as having not received to grade ≤ 1 (with the exception of alopecia and laboratory values listed per the inclusion criteria). Patients with irreversible toxicity that is not reasonably expected to be exacerbated by NT-I7 may be included (e.g., hearing loss, peripheral neuropathy) after consultation with the PI.

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection (including active hepatitis A or mycobacterium tuberculosis (testing not required))

Congestive heart failure with NYHA Class ≥ 2

Uncontrolled atrial fibrillation

Any of the following within 6 months prior to day of CAR T-cell administration:

Unstable angina pectoris

Myocardial infarction

Coronary artery bypass grafting

Coronary angioplasty

Coronary stenting

Clinically significant cardiac arrhythmia and/or conduction abnormality

Other clinically significant cardiac disease that, in the opinion of the treating physician and/or PI, is a contraindication to study treatment

History of autoimmune disease for the past 2 years prior to enrollment, including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.

NOTE: The following are exceptions to this criterion: vitiligo, alopecia, type 1 diabetes mellitus, autoimmune hypothyroidism stable on hormone replacement, psoriasis not severe enough to require systemic treatment, diverticulitis not associated with inflammatory bowel disease.

Contraindication to intramuscular therapy.

Receipt of a live, attenuated vaccine within 30 days prior to NT-I7 injection.

NOTE: Patients, if enrolled, should not receive live vaccines during the study period and through 30 days after the last NT-I7 injection. The administration of inactivated vaccines is permitted at any time per the discretion of the treating physician.

Pregnant and/or breastfeeding and/or expecting to conceive or father children within the study duration (from enrollment through 90 days after last dose of NT-I7). Women of childbearing potential (including women who have had a tubal ligation) must have a negative serum or urine pregnancy test within 72 hours prior to CAR-T administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible.

Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible.

History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible.

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 (NCT07052305) 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.

Large B-cell Lymphoma Treatment Options in St Louis, MO

If you're searching for large b-cell lymphoma treatment options in St Louis, MO, this clinical trial (NCT07052305) 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 large b-cell lymphoma 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 large b-cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Large B-cell Lymphoma Clinical Trial in St Louis, MO

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