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

Running, not enrolling · Phase 1

Conditions studied: Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia

In brief

SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

Key facts

Study ID

NCT05878184

Run by

Sana Biotechnology

People needed

16

Starts

2023-05-02

Expected to finish

2038-11-04

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required)
• History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
• Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics)
• Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time).
• Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >20 mg/day prednisone or equivalent).
• History or presence of cardiac or CNS disorders as defined in the protocol

Where it is running

• City of Hope — Duarte, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• Northside Hospital — Atlanta, Georgia, United States
• University of Kansas Medical Center — Fairway, Kansas, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia

Full record on ClinicalTrials.gov

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