Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID)

Large B-cell Lymphoma Clinical Trial

Official title:

A Phase 1 Study Evaluating SC262, a Hypoimmune, Allogeneic CD22-directed CAR T Cell Therapy, in Relapsed and/or Refractory Non-Hodgkin's Lymphoma (VIVID)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285422
• Other study ID #: SC262-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non Hodgkin's Lymphoma

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