An early phase clinical trial to investigate EO2463, a novel cancer vaccine therapy, in patients with indolent Non-Hodgkin's Lymphoma.
- Conditions
- Indolent Non-Hodgkin's Lymphoma (Follicular LymphomaMarginal Zone Lymphoma)MedDRA version: 22.0Level: PTClassification code: 10029547Term: Non-Hodgkin's lymphoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509254-58-00
- Lead Sponsor
- Enterome
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 54
For inclusion in Cohorts 1 and 4 patients should have relapsed/refractory, biopsy-proven grade 1, 2 or 3A, FL or MZL*, ECOG performance status 0 to 2, and have received at least one prior line of treatment, For inclusion in Cohort 2 patients should have newly diagnosed, previously untreated (non-definitive radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL*, Ann Arbor stage III or IV, or Ann Arbor stage I or II when the patient is not eligible for definitive radiotherapy, ECOG performance status 0 or 1, low tumor burden by GELF criteria (low tumor burden defined as: no mass > 7 cm, < three masses >3 cm, no systemic or B-symptoms, no splenomegaly > 16 cm by scan (PET/CT or CT), no risk of vital organ compression, no leukemic phase > 5,000/µL circulating lymphocytes, and no cytopenia [defined as platelets < 100,000/µL, hemoglobin < 10 g/dL, or absolute neutrophil count <1,500/µL]), and not be in need of standard of care therapy according to the assessment of the treating physician., For inclusion in Cohort 3 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL*, Ann Arbor stage III or IV, ECOG performance status 0 or 1, low tumor burden by GELF criteria (low tumor burden defined as: no mass > 7 cm, < three masses >3 cm, no systemic or B-symptoms, no splenomegaly > 16 cm by PET/CT or CT scan, no risk of vital organ compression, no leukemic phase > 5,000/µL circulating lymphocytes, and no cytopenia [defined as platelets < 100,000/µL, hemoglobin < 10 g/dL, or absolute neutrophil count <1,500/µL]), and be in need of therapy according to the assessment of the treating physician. * MZL includes the entities extranodal MZL (EMZL, i.e. MALT lymphoma), splenic MZL (SMZL), and nodal MZL (NMZL)., Patients with an age = 18 years old., Patients who are human leukocyte antigen (HLA)-A2 positive., Patients should have radiologically measurable disease with a lymph node or tumor mass greater than or equal to 1.5 cm in at least one dimension., Males or non-pregnant, non-lactating, females who are: a. female, post-menopausal (as defined in the protocol), b. female and male, surgically sterile (as defined in the protocol), c. female of childbearing potential with a negative highly sensitive serum pregnancy test within 72 hours prior to first administration of study treatment and use of a highly effective contraception from signing the Informed Consent Form (ICF) through the 30 days safety visit after the last study treatment dose administered; note, the male partner should in addition to the use of highly effective contraception by the female patient also use condoms, d. male patient with female partners of childbearing potential must use condoms from signing the ICF through the 30 days safety visit after the last study treatment dose administered; in addition, male patients must ensure that their partners of childbearing potential also use highly effective contraception as described in the protocol. In addition, for patients who are to be enrolled in a cohort including rituximab the following inclusion criteria are applicable: e. due to the long retention time of rituximab in patients with B cell depletion, females of childbearing potential must commit to use effective contraceptive methods (see protocol inclusion criteria 7d for details) during and for 12 months following treatment with rituximab. In addition, for pat
Patients treated with dexamethasone > 2 mg/day or equivalent (i.e. 13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14 days before the first EO2463 administration., Patients who have received live or attenuated vaccine therapy used for prevention of infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the first dose of study drug., Patients with a history of hypersensitivity to any excipient, or active substance, present in the pharmaceutical forms of applicable study treatments. In addition, patients with hypersensitivity to murine proteins should not receive rituximab., Patients with grade 3B FL or transformation to an aggressive lymphoma subtype., Patients treated with herbal remedies with immune stimulating properties or known to potentially interfere with major organ function., Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment)., Patients with prior exposure to EO2463., Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion/exclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2463 administration., Patients to be included in Cohorts 1 and 4, and who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment., Patients to be included in Cohorts 1 and 4, and who have already progressed during prior treatment with the R2-regimen, i.e. an adequate combination of lenalidomide and rituximab., Patients with abnormal laboratory values, Active central nervous system (CNS) metastasis; patients with history of CNS metastases are eligible if CNS disease has been radiographically and neurologically stable for at least 6 weeks prior to ICF signing and do not require corticosteroids (of any dose; for the CNS disease specifically) for symptomatic management., Patients with persistent Grade 3 or 4 toxicities (according to NCI-CTCAE v5.0) after prior treatments; toxicities must be resolved since at least 2 weeks before study treatment start to Grade 1 or less. However, alopecia or other persisting toxicities Grade = 2 not constituting a safety risk based on Investigator’s judgment are acceptable., Patients to be included in Cohorts 4, who received prior CAR T-cell therapy and progressed within 6 months after this therapy., Other malignancy or prior malignancy with a disease-free interval of less than 3 years prior to ICF signing; except those treated with surgical intervention and an expected low likelihood of recurrence such as basal cell or squamous cell skin cancer, or carcinoma in situ, e.g. patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible., Patients with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition that, in the opinion of the Investigator, would make the administration of study drug hazardous to the patient, interfere with the evaluation of study results, interpretation of patient safety, or prohibit patient understanding of the informed consent procedure or compliance with the requirements of the protocol., Patients with suspected autoimmune
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method