A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205]
Key facts
- Who runs it
- Sanofi
- Where
- Argentina, Chile, and Spain8 sites in 3 countriesChoose a country to see its sites
- Trial code
- NCT05179603
- EudraCT 2021-002150-91
- U1111-1251-5834
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 14 people enrolled
- Started
- 7 Dec 2021
- Ended
- 6 Sept 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- THOR-707
- Pembrolizumab
- Record updated
- 24 December 2025
- Why it stopped
- Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Who can take part
- Age
- 12 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participants with baseline oxygen saturation (SpO2) ≤ 92% (without oxygen therapy)
- 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
- 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
- History of allogenic or solid organ transplant
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2 (≥ 16 years old). Lansky Scale (< 16 years old) ≤ 60%
- Participants were excluded from the study if any of the following criteria applied:
- Poor bone marrow reserve
- Poor organ function
- Lymphomatous involvement of the central nervous system
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a phase 2 multi-cohort, un-controlled, non-randomized, open-label, multi-center study that assessed the antitumor activity and safety of non-alpha interleukin (IL-2) SAR444245 with or without other anticancer therapies in participants aged 12 years and older with relapsed or refractory B cell lymphoma. This study was structured as a master protocol with separate sub studies designed to investigate the use of SAR444245 either with or without other anticancer therapies for the treatment of relapsed or refractory B cell lymphoma.
Read full original descriptionShow less
Substudy 1-Cohort A aimed to establish safety and preliminary anti-tumor activity for non-alpha interleukin (IL-2) SAR444245 combined with the anti-PD1 antibody, pembrolizumab in trial participants with classic Hodgkin lymphoma (cHL) who are anti-PD-(L)1-naive and have received at least 2 or 3 lines of systemic therapy.
Substudy 3-Cohort C1 aims to establish safety and preliminary anti-tumor activity for SAR444245 as monotherapy in trial participants with diffuse large B-cell lymphoma (DLBCL). Trial participants in this study must have received at least 2 lines of systemic therapy and have either stable or progressive disease 1-3 months post Health Authority approved Chimeric Antigen Receptor T-cell (CAR-T) treatment when given as last systemic treatment prior to study enrollment.
The 2 groups in the trial
- Cohort A: Pegenzileukin 24 μg/kg + PembrolizumabTreatment being tested
Participants with classic Hodgkin lymphoma (cHL) who were anti-programmed cell death-ligand 1 (PD-L1)-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 microgram per kilogram (μg/kg) via intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 milligram (mg) via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as third-line or fourth-line (3/4L) therapy, until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
Treatment: THOR-707 and Pembrolizumab
- Cohort C1: (sub study 03) diffuse large B Cell lymphoma (DLBCL)Treatment being tested
Pegenzileukin administered every 2 weeks on Day 1 of each cycle (14 days per cycle) for up to 52 cycles.
Treatment: THOR-707
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase 2 Non-randomized, Open-label, Multi-cohort, Multicenter Study Assessing the Clinical Benefit of SAR444245 (THOR-707) With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma
- Record updated
- 24 December 2025