An early phase clinical trial to investigate EO2463, a novel cancer vaccinetherapy, in patients with indolent Non-Hodgkin's Lymphoma.

Phase 1

• Conditions: Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma; Marginal Zone Lymphoma); MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003999-40-IT
• Lead Sponsor: ENTEROME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-30
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Cohorts 1 and 4 patients should have relapsed/refractory, biopsyproven grade 1, 2 or 3A, FL or MZL, ECOG performance status 0 to 2, and

have received at least one prior line of treatment (no limitation in

number of prior treatments; radiotherapy by itself is not considered a

line of
treatment).
2. Cohort 2 patients should have newly diagnosed, previously untreated

(non-definitive radiotherapy as only prior treatment is allowed),
biopsyproven 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, and not be in need of

standard of care therapy according to the assessment of the treating

physician.
3. 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
Bsymptoms, 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).
4. Patients with an age = 18 years
old.
5. Patients who are human leukocyte antigen (HLA)-A2
positive.
6. 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.

Insufficient space, refer to the Protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Patients treated with dexamethasone > 2 mg/day or equivalent (ie 13
mg/day of prednisone or 53 mg/day of hydrocortisone) within 14 days
before the first EO2463 administration.
2. Patients with grade 3B FL or transformation to an aggressive
lymphoma subtype.
3. 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).
4. Patients with prior exposure to EO2463.
5. 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.
6. 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.
7. Patients to be included in Cohorts 1 and 4, and who have already
progressed during prior treatment with the R^2-regimen, i.e. an
adequate combination of lenalidomide and rituximab.
8. Patients with abnormal laboratory values according to the following
list (note, lab ranges according to the performing laboratory's reference
ranges):
a. hemoglobin < 8 g/dL (sample should be taken = 7 days after any red
blood cell transfusion),
b. absolute neutrophil count decrease (< 1.0 ×10^9 /L) (sample should
be taken = 7 days after any growth factor administration),
c. platelet count decrease (< 75 ×10^9 /L) (sample should be taken = 7
days after any platelet transfusion),
d. bilirubin > 1.5 x upper limit of normal (ULN) (benign hereditary
hyperbilirubinemia, e.g. Gilbert's syndrome is permitted),
e. alanine aminotransferase (ALT) > 3 x ULN; if disease affecting the
liver > 5 x ULN,
f. aspartate aminotransferase (AST) > 3 x ULN; if disease affecting the
liver > 5 x ULN, and
g. serum creatinine increase (> 1.5 x ULN).

Insufficient space, refer to the Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified