NT-I7 (Efineptakin Alfa) with CAR T-cell Therapy for Relapsed/Refractory Large B-cell Lymphoma
This study is testing a drug called NT-I7 (Efineptakin Alfa) in people with large B-cell lymphoma that has come back or hasn't responded to previous treatments (relapsed/refractory). NT-I7 works by helping your body's T-cells grow and multiply. Participants will receive standard CAR T-cell therapy (either axicabtagene ciloleucel or lisocabtagene maraleucel), which is an approved treatment that uses your own specially modified immune cells to fight cancer. The study aims to find out how safe NT-I7 is and what dose works best when given after CAR T-cell therapy. To join, you must be at least 18 years old and have large B-cell lymphoma that can be measured. The study plans to enroll 24 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored for at least 90 days after CAR T-cell infusion, and the best dose of NT-I7 will be determined within approximately 35 days after the first dose.
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NCT07052305
NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~24 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:NT-I7CAR T-cell therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over From start of CAR T-cell infusion (day 0) through day 90 (post CAR T-cell infusion)
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Zachary D Crees, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
Exclusion
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.
What this trial measures
- Incidence of adverse eventsFrom start of CAR T-cell infusion (day 0) through day 90 (post CAR T-cell infusion)
Measured per CTCAE v 5.0. CRS and ICANS will be graded per ASTCT guidelines
- Maximum tolerated dose of NT-I7 (Dose Escalation only)From first dose of NT-I7 until 14 days after the second dose NT-I7 dose (estimated to be 35 days)
Determined by incidence and nature of dose-limiting toxicities (DLTs). DLTs are defined in the protocol.
- Recommended phase 2 dose of NT-I7 (Dose Escalation only)Through 90 days after CAR T-cell infusion
Determined by the potential correlation of dose levels with safety and efficacy parameters.