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

NCT ID: NCT05878184

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2038-11-04

Brief Summary

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

Detailed Description

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.

Conditions

Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SC291 Plus Chemotherapy Regimen

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291

Group Type: EXPERIMENTAL

SC291

Intervention Type: DRUG

SC291 is an allogeneic CAR-T cell therapy

Interventions

SC291

SC291 is an allogeneic CAR-T cell therapy

Intervention Type: DRUG

Other Intervention Names

Cyclophosphamide; Fludarabine

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sana Biotechnology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Gerecitano, MD, PhD

Role: STUDY_DIRECTOR

Sana Biotechnology, Inc.

Locations

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

Countries

United States; Australia

Other Identifiers

SC291-101

Identifier Type: -

Identifier Source: org_study_id