Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT07052305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712767', 'term': 'efineptakin alfa'}, {'id': 'D016219', 'term': 'Immunotherapy, Adoptive'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'From start of CAR T-cell infusion (day 0) through day 90 (post CAR T-cell infusion)', 'description': 'Measured per CTCAE v 5.0. CRS and ICANS will be graded per ASTCT guidelines'}, {'measure': 'Maximum tolerated dose of NT-I7 (Dose Escalation only)', 'timeFrame': 'From first dose of NT-I7 until 14 days after the second dose NT-I7 dose (estimated to be 35 days)', 'description': 'Determined by incidence and nature of dose-limiting toxicities (DLTs). DLTs are defined in the protocol.'}, {'measure': 'Recommended phase 2 dose of NT-I7 (Dose Escalation only)', 'timeFrame': 'Through 90 days after CAR T-cell infusion', 'description': 'Determined by the potential correlation of dose levels with safety and efficacy parameters.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'Through completion of follow-up (estimated to be 1 year)', 'description': 'Response will be assessed based on IWG response criteria for lymphoma'}, {'measure': 'Partial response (PR) rate', 'timeFrame': 'Through completion of follow-up (estimated to be 1 year)', 'description': 'Response will be assessed based on IWG response criteria for lymphoma'}, {'measure': 'Complete response (CR) rate', 'timeFrame': 'Through completion of follow-up (estimated to be 1 year)', 'description': 'Response will be assessed based on IWG response criteria for lymphoma'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Through completion of follow-up (estimated to be 1 year)', 'description': 'For responders only: defined as the time from the first occurrence of a documented objective response (PR or CR) to the time of the first documented disease progression or death from any cause, whichever occurs first, per IWG.\n\nResponse will be assessed based on IWG response criteria for lymphoma'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Through completion of follow-up (estimated to be 1 year)', 'description': 'Defined as the time from the CAR T-cell infusion (Day 0) to the first occurrence of progression or death from any cause, whichever occurs first, per IWG.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through completion of follow-up (estimated to be 1 year)', 'description': 'Defined as the time from CAR T-cell infusion (Day 0) to death from any cause.'}, {'measure': 'Effect of NT-I7 on CAR T-cell expansion kinetics as measured by area under the concentration time-curve (AUC)', 'timeFrame': 'From day 0 to day 42 post CAR T-cell infusion', 'description': 'Measured by quantitative DNA PCR and/or flow cytometry.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Hodgkins Lymphoma', 'Large B-cell Lymphoma', 'Yescarta', 'Axi-cel', 'Breyanzi', 'Liso-cel', 'Interleukin 7', 'NT-I7', 'CD19 CAR T-cell Therapy'], 'conditions': ['Large B-cell Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': '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 Yescarta and Breyanzi (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed/refractory large B-cell lymphoma.\n\nIL-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.\n\nNT-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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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. Tumor tissue (fresh or archival) must have been tested to confirm the histologic diagnosis.\n* Measurable disease by IWG response criteria for lymphoma.\n\n * Baseline FDG-PET/CT scan must show FDG-avid lesions compatible with CT-defined anatomical tumor sites but will not be used in subsequent clinical decisions.\n * A previously irradiated lesion can be considered a target lesion if it is well defined, measurable, and has clearly progressed.\n * Patients who receive bridging therapy pre-lymphodepletion will be allowed for enrollment regardless of restaging results (PMR or CMR), even if the lesion is not measurable per the criteria mentioned above.\n * FDG-PET/CT scans done as SOC up to 28 days pre-lymphodepletion therapy will be allowed.\n* Eligible for treatment with an FDA-approved SOC CD19 CAR T-cell therapy respective to the current FDA-approved CAR T-cell label for Yescarta or Breyanzi.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* 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 (labs outside of these ranges may be considered for inclusion after consultation with the PI):\n\n * Absolute neutrophil count ≥ 1.0 K/cumm\n * Platelets ≥ 50 K/cumm\n * Hemoglobin ≥ 8.0 g/dL\n * 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)\n * 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)\n * Alkaline phosphatase ≤ 2.5 x IULN (except for patients with liver metastasis, who must have an alkaline phosphatase ≤ 5.0 x IULN)\n * 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\n * NOTE: Cytopenias resulting from disease or bridging therapy will not be considered exclusionary.\n* ECG demonstrating Fridericia's corrected QT interval (QTcF) \\< 500 ms; patients with QTcF ≥ 500 ms will require clearance by a local cardiologist.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Previous receipt of an allogeneic solid organ transplant or bone marrow transplant.\n* 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.\n* Currently receiving chemotherapy or biologic or hormonal therapy for cancer treatment, or received within 14 days prior to the first NT-I7 injection.\n\n * NOTE: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable.\n* Currently receiving any other investigational agents, or received within 14 days prior to the first NT-I7 injection.\n* Documented active central nervous system (CNS) involvement by lymphoma.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to NT-I7 or other agents used in the study.\n* 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.\n* Uncontrolled intercurrent illness including, but not limited to:\n\n * Ongoing or active infection (including active hepatitis A or mycobacterium tuberculosis (testing not required))\n * Congestive heart failure with NYHA Class ≥ 2\n * Uncontrolled atrial fibrillation\n * Any of the following within 6 months prior to day of CAR T-cell administration:\n\n * Unstable angina pectoris\n * Clinically significant myocardial infarction\n * Coronary artery bypass grafting\n * Coronary angioplasty\n * Coronary stenting\n * Clinically significant cardiac arrhythmia and/or conduction abnormality\n * Other clinically significant cardiac disease that, in the opinion of the treating physician and/or PI, is a contraindication to study treatment\n* 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.\n\n * 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.\n* Intramuscular therapy is contraindicated.\n* Receipt of a live, attenuated vaccine within 30 days prior to NT-I7 injection.\n\n * 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.\n* Pregnant and/or breastfeeding and/or expecting to conceive or father children within the study duration (from enrollment through 120 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.\n* 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.\n* 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.\n* 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."}, 'identificationModule': {'nctId': 'NCT07052305', 'briefTitle': 'NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': '25-x234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Dose Level 1 Starting Dose: NT-I7', 'description': 'NT-I7 will be administered as an intramuscular injection at 600 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections.', 'interventionNames': ['Drug: NT-I7', 'Biological: CAR T-cell therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Dose Level 2: NT-I7', 'description': 'NT-I7 will be administered as an intramuscular injection at 720 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections.', 'interventionNames': ['Drug: NT-I7', 'Biological: CAR T-cell therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion (RP2D): NT-I7', 'description': 'NT-I7 will be administered as an intramuscular injection at the recommended phase 2 dose on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections.', 'interventionNames': ['Drug: NT-I7', 'Biological: CAR T-cell therapy']}], 'interventions': [{'name': 'NT-I7', 'type': 'DRUG', 'otherNames': ['Efineptakin alfa'], 'description': 'Provided by NeoImmune Tech', 'armGroupLabels': ['Dose Escalation Dose Level 1 Starting Dose: NT-I7', 'Dose Escalation Dose Level 2: NT-I7', 'Dose Expansion (RP2D): NT-I7']}, {'name': 'CAR T-cell therapy', 'type': 'BIOLOGICAL', 'description': 'Will be given on day 0', 'armGroupLabels': ['Dose Escalation Dose Level 1 Starting Dose: NT-I7', 'Dose Escalation Dose Level 2: NT-I7', 'Dose Expansion (RP2D): NT-I7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'contacts': [{'name': 'Zachary D Crees, M.D.', 'role': 'CONTACT', 'email': 'zcrees@wustl.edu', 'phone': '314-273-1039'}, {'name': 'Zachary D Crees, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John F DiPersio, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Feng Gao, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Zachary D Crees, M.D.', 'role': 'CONTACT', 'email': 'zcrees@wustl.edu', 'phone': '314-273-1039'}], 'overallOfficials': [{'name': 'Zachary D Crees, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeoImmuneTech', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}