Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID)

Phase 1

Recruiting

• Conditions: Large B-cell Lymphoma; Non Hodgkin's Lymphoma
• Interventions: Drug: SC262

• Registration Number: NCT06285422
• Lead Sponsor: Sana Biotechnology

Brief Summary

SC262-101 is a Phase 1 study to evaluate SC262 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 SC262 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with Non Hodgkin's Lymphoma (NHL) who have received no more than 1 prior CD19-directed Chimeric Antigen Receptor T-Cells (CAR T) cell therapy. This study will be conducted in 2 parts. Dose finding using a 3+3 design in subjects with NHL. Dose expansion to further evaluate safety and efficacy at the recommended phase 2 dose (RP2D) in subjects with Large B-Cell Lymphoma (LBCL).

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Study Start: 2024-04-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2028-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Male or Female Subject aged 18-80 years at the time of signing the informed consent

2. Histologic diagnosis of NHL (based on World Health Organization 2016 criteria) including:

   • LBCL, including Diffuse Large B Cell Lymphoma (DLBCL) not otherwise specified (NOS) (including DLBCL arising from indolent lymphoma), Primary Mediastinal Large B-Cell Lymphoma (PMBCL), High-Grade B-Cell Lymphoma (HGBCL), and Follicular Lymphoma (FL) Grade 3B
   • FL
   • Marginal Zone Lymphomas (MZL)
   • Mantle Cell Lymphoma (MCL)

3. Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

5. At least 1 measurable (PET-positive) lesion per Lugano classification

6. Life expectancy ≥12 Weeks

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Exclusion Criteria

1. Prior CD22-directed therapy including CD22-directed CAR T cell therapy or other CD22 -directed antibody or cell therapy (e.g., Natural Killer (NK) cell)
2. History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment.
3. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time)
4. Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >10 mg/day prednisone or equivalent)
5. History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, within 12 months of enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SC262 Plus Chemotherapy Regimen	SC262	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262

Primary Outcome Measures

Name	Time	Method
Evaluate safety and tolerability of SC262	24 months	Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Evaluate preliminary anti-tumor activity of SC262	24 months	Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response)
Evaluate cellular kinetics and persistence of SC262	24 months	Area under the concentration time curve (AUC) in peripheral blood
Evaluate host immunogenicity to SC262	24 months	Incidence of anti-CD19-directed CAR antibodies

Trial Locations

Locations (3)

The University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States