EUCTR2021-002150-91-ITActive, not recruitingPhase 1
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 - NA
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 sites60 target enrollmentStarted: January 27, 2022Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Participants must be >/= 12 years of age, at the time of signing the informed consent
- •- Disease location amenable to tumor biopsy at baseline
- •- All participants must have a measurable disease
- •- Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
- •* to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment
- •* and to refrain from donating or cryopreserving eggs for 180 days after
- •discontinuing study treatment.
- •- Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
- •- Capable of giving signed informed consent
- •For cohort A (substudy 01): Histologically or cytologically confirmed diagnosis of 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 (substudy 03): Histologically or cytologically confirmed diagnosis of DLBCL, must have received at least two prior lines of systemic therapy for DLBCL, including at least one containing a combination of anthracycline and rituximab (or another anti-CD20 agent), with the last line of therapy a marketed CD19- directed CAR-T therapy.
- •Are the trial subjects under 18? yes
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
Exclusion Criteria
- •- Eastern Cooperative Oncology Group (ECOG) performance status of >/= 2 (>/= 16 years old). Lansky Scale (< 16 years old) < 50%.
- •- Poor bone marrow reserve
- •- Poor organ function
- •- Participants with baseline SpO2 - Lymphomatous involvement of the central nervous system.
- •- History of allogenic or solid organ transplant
- •- Last administration of prior antitumor therapy or any investigational treatment within 21 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 21 days.
- •- Has received prior IL-2-based anticancer treatment.
- •- Comorbidity requiring corticosteroid therapy
- •- Antibiotic use (excluding topical antibiotics) - Severe or unstable cardiac condition within 6 months prior to starting study treatment
- •- 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 are permitted.
Investigators
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