Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT05179603
Eligibility Criteria:
Inclusion Criteria:
* Participants must have been ≥ 12 years of age, at the time of signing the informed consent
* Disease location was amenable to tumor biopsy at baseline
* All participants must have had a measurable disease
* Both male and female participants agreed to use approved contraception methods; not pregnant or breastfeeding for female participants; no donation or cryopreservation of eggs (ova, oocytes) for female participants and sperms for male participants.
* Had to be capable of giving signed informed consent
For cohort A: Histologically or cytologically confirmed diagnosis of classic Hodgkin lymphoma (cHL), must have received at least two prior lines of systemic therapy for cHL, including at least one containing an anthracycline or brentuximab.
For cohort C1: Histologically confirmed diagnosis of diffuse large B Cell lymphoma (DLBCL), must have received at least two prior lines of systemic therapy for DLBCL, including one containing a combination of anthracycline and rituximab (or another anti-CD20 agent), with the last line of therapy a Health Authority approved CD19-directed CAR-T therapy. Patients must have BOR (Best Overall Response) of stable disease (SD) or progressive disease (PD) after CD-19 directed CAR-T therapy.
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria applied:
* Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2 (≥ 16 years old). Lansky Scale (\< 16 years old) ≤ 60%
* Poor bone marrow reserve
* Poor organ function
* Participants with baseline oxygen saturation (SpO2) ≤ 92% (without oxygen therapy)
* Lymphomatous involvement of the central nervous system
* History of allogenic or solid organ transplant
* Prior IV or subcutaneous anticancer therapy, investigational agent, major surgery within 21 days prior to initiation of IMP; oral anticancer therapy within 5 half-lives or completed palliative radiotherapy within 21 days prior to initiation of IMP
* Has received prior IL-2-based anticancer treatment
* Comorbidity requiring corticosteroid therapy
* Antibiotic use (excluding topical antibiotics) ≤ 14 days prior to first dose of IMP
* Severe or unstable cardiac condition within 6 months prior to starting study treatment
* Had active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years-Known second malignancy either progressing or requiring active treatment within the last 3 years
* Receipt of a live or live attenuated virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines or SARS-CoV-2 vaccine that do not contain live virus were permitted
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05179603
Study Brief:
Protocol Section:
NCT05179603