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

NCT05878184 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SC291-101
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia

Keywords

Large B cell lymphoma; CAR T Cell Therapy; Mantle cell lymphoma; Indolent follicular lymphoma; Marginal zone lymphoma; High-grade B cell lymphoma; Primary mediastinal B cell lymphoma; Diffuse large B cell lymphoma; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Allogeneic; Hypoimmune; CD19

Outcome Measures

Primary Outcomes (1)

• Evaluate safety and tolerability of SC291

  Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

  24 months

Secondary Outcomes (5)

• Evaluate preliminary anti-tumor activity of SC291

  24 months

• Evaluate cellular kinetics and persistence of SC291

  24 months

• Evaluate cellular kinetics and persistence of SC291

  24 months

• Evaluate cellular kinetics and persistence of SC291

  24 months

• Evaluate host immunogenicity to SC291

  24 months

Study Arms (1)

SC291 Plus Chemotherapy Regimen

EXPERIMENTAL

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

Drug: SC291

Interventions

SC291 DRUG

SC291 is an allogeneic CAR-T cell therapy

Also known as: Cyclophosphamide, Fludarabine

SC291 Plus Chemotherapy Regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sana Biotechnology: lead

Study Sites (10)

City of Hope

Duarte, California, 91010, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• John Gerecitano, MD, PhD

  Sana Biotechnology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 26, 2023
• Study Start: May 2, 2023
• Primary Completion: November 4, 2025
• Study Completion (Estimated): November 4, 2038
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); AU (3)