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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06285422
Other study ID # SC262-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 2024
Est. completion date March 2029

Study information

Verified date May 2024
Source Sana Biotechnology
Contact Ndidi Onwudiwe
Phone (206) 791 3731
Email vivid@sana.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date March 2029
Est. primary completion date March 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Drug:
SC262
SC262 is an allogeneic CAR -T cell therapy

Locations

Country Name City State
United States Swedish Cancer Institute Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Sana Biotechnology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate safety and tolerability of SC262 Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities 24 months
Secondary Evaluate preliminary anti-tumor activity of SC262 Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response) 24 months
Secondary Evaluate cellular kinetics and persistence of SC262 Cellular kinetics related peak (Cmax) in peripheral blood 24 months
Secondary Evaluate cellular kinetics and persistence of SC262 Cellular kinetics-related parameters evaluated by CAR T cell copy number 24 months
Secondary Evaluate cellular kinetics and persistence of SC262 Area under the concentration time curve (AUC) in peripheral blood 24 months
Secondary Evaluate host immunogenicity to SC262 Incidence of anti-CD19-directed CAR antibodies 24 months
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