NCT06285422

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
34mo left

Started Apr 2024

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Apr 2024Mar 2029

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 18, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

February 22, 2024

Last Update Submit

November 21, 2025

Conditions

Non Hodgkin's LymphomaLarge B-cell Lymphoma

Keywords

Large B-Cell LymphomaCAR T Cell TherapyMantle Cell LymphomaFollicular LymphomaMarginal Zone LymphomaHigh-Grade B-Cell LymphomaPrimary Mediastinal B-Cell LymphomaDiffuse Large B-Cell LymphomaNon-Hodgkin's LymphomaAllogeneicHypoimmuneCD22SC262

Outcome Measures

Primary Outcomes (1)

  • Evaluate safety and tolerability of SC262

    Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

    24 months

Secondary Outcomes (5)

  • Evaluate preliminary anti-tumor activity of SC262

    24 months

  • Evaluate cellular kinetics and persistence of SC262

    24 months

  • Evaluate cellular kinetics and persistence of SC262

    24 months

  • Evaluate cellular kinetics and persistence of SC262

    24 months

  • Evaluate host immunogenicity to SC262

    24 months

Study Arms (1)

SC262 Plus Chemotherapy Regimen

EXPERIMENTAL

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

Drug: SC262

Interventions

SC262DRUG

SC262 is an allogeneic CAR -T cell therapy

Also known as: Cyclophosphamide, Fludarabine
SC262 Plus Chemotherapy Regimen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female Subject aged 18-80 years at the time of signing the informed consent
  • 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
  • Marginal Zone Lymphomas (MZL)
  • Mantle Cell Lymphoma (MCL)
  • Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • At least 1 measurable (PET-positive) lesion per Lugano classification
  • Life expectancy ≥12 Weeks

You may not qualify if:

  • 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)
  • History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment.
  • Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time)
  • Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as \>10 mg/day prednisone or equivalent)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Mantle-CellLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • John Gerecitano, MD, PhD

    Sana Biotechnology, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

April 18, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

March 1, 2029

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations

US(3)