Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
Leukemia
Non-Hodgkin Lymphoma
18 - 80 Years, Male and Female
SC291-101 (primary)
NCI-2023-04424
Summary
SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor
activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Objectives
This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the
safety and tolerability of SC291 administered intravenously (IV) following a standard
lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with
NHL or CLL who have received two or more prior systemic treatments per standard of care
(or after autologous stem cell transplant [ASCT] for NHL). This study will be conducted
in 2 parts. Phase 1a: dose finding using a 3+3 design in subjects with NHL or CLL. Phase
1b: dose expansion to further evaluate safety and efficacy at the RP2D in subjects with
LBCL and CLL.
Eligibility
- Male or female subjects aged 18-80 years at the time of signing informed consent.
- Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including:
- Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise
- - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B
- Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B)
- Marginal zone lymphoma (dose escalation only)
- Mantle cell lymphoma (dose escalation only)
- CLL or SLL
- Relapsed/refractory disease after at least 2 prior systemic regimens per standard of care or after autologous stem cell transplant
- ECOG performance status of 0 or 1.
- At least one measurable lesion per Lugano Classification (NHL); CLL subjects must meet iwCLL treatment criteria
- Life expectancy =12 weeks
Treatment Sites in Georgia
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523
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