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

Sana Biotechnology

Status and phase: Enrolling; Phase 1

Conditions: Large B-cell Lymphoma; Non Hodgkin's Lymphoma

Treatments: Drug: SC262

Study type: Interventional

Funder types: Industry

Identifiers

NCT06285422

SC262-101

Details and patient eligibility

About

SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

Full 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).

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

SC262 Plus Chemotherapy Regimen

Experimental group

Description:

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262

Treatment:

Drug: SC262