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

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sana Biotechnology

Criteria

Inclusion Criteria:

• Male or female subjects aged 18-75 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

Exclusion Criteria:

• 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