Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)

Active:	Yes
Cancer Type:	Leukemia Non-Hodgkin Lymphoma	NCT ID:	NCT05878184
Trial Phases:	Phase I	Protocol IDs:	SC291-101 (primary) NCI-2023-04424
Eligibility:	18 - 80 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Sana Biotechnology
NCI Full Details:	http://clinicaltrials.gov/show/NCT05878184

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.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523

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