Clinical trial NCT06285422: Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non Hodgkin's Lymphoma
Large B-cell Lymphoma
Keywords: Large B-Cell Lymphoma
CAR T Cell Therapy
Mantle Cell Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
High-Grade B-Cell Lymphoma
Primary Mediastinal B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Non-Hodgkin's Lymphoma
Allogeneic
Hypoimmune
CD22
SC262
Lead sponsor: Sana Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate safety and tolerability of SC262
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate preliminary anti-tumor activity of SC262
timeFrame: 24 months
measure: Evaluate cellular kinetics and persistence of SC262
timeFrame: 24 months
measure: Evaluate cellular kinetics and persistence of SC262
timeFrame: 24 months
measure: Evaluate cellular kinetics and persistence of SC262
timeFrame: 24 months
measure: Evaluate host immunogenicity to SC262
timeFrame: 24 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Sana Biotechnology, Inc.
name: Cori Abikoff, MD
role: STUDY_DIRECTOR
References: