Non Hodgkin's LymphomaPhase 1NCT06285422
Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID)
A Phase 1 study testing SC262 in people with Non Hodgkin's Lymphoma and Large B-cell Lymphoma, run by Sana Biotechnology at 3 sites in United States.
Trial summary
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Hodgkin's Lymphoma, Large B-cell Lymphoma
- What is being tested?
- SC262
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Apr 2024to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- FL
- Marginal Zone Lymphomas (MZL)
- Mantle Cell Lymphoma (MCL)
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Kansas Hospital
Kansas City, Kansas, 66160
Swedish Cancer Institute
Seattle, Washington, 98104
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
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)
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Read the 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).
- Conditions
- Non Hodgkin's Lymphoma, Large B-cell Lymphoma
- Being tested
- SC262
- 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
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC262Drug
Also called Cyclophosphamide, Fludarabine
SC262 is an allogeneic CAR -T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| SC262 Plus Chemotherapy Regimen | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262 Receives: Drug: SC262 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability of SC262
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Measured: 24 months
Secondary outcomes (5)
Evaluate preliminary anti-tumor activity of SC262
Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response)
Measured: 24 months
Evaluate cellular kinetics and persistence of SC262
Cellular kinetics related peak (Cmax) in peripheral blood
Measured: 24 months
Evaluate cellular kinetics and persistence of SC262
Cellular kinetics-related parameters evaluated by CAR T cell copy number
Measured: 24 months
Evaluate cellular kinetics and persistence of SC262
Area under the concentration time curve (AUC) in peripheral blood
Measured: 24 months
Evaluate host immunogenicity to SC262
Incidence of anti-CD19-directed CAR antibodies
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start18 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Gerecitano, MD, PhD, Study director, Sana Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285422
- Sponsor's protocol ID
- SC262-101
- Status last verified
- Nov 2025
- First submitted
- 22 Feb 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06285422
- Acronym / sponsor ID
- SC262-101
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Sana BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC262 Plus Chemotherapy Regimen | Experimental | Drug: SC262A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC262Also: Cyclophosphamide, FludarabineSC262 is an allogeneic CAR -T cell therapy | Drug | SC262 Plus Chemotherapy Regimen |
Primary outcome
Evaluate safety and tolerability of SC262
Time frame: 24 months
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
5 secondary outcomes
Evaluate preliminary anti-tumor activity of SC262
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC262
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC262
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC262
Time frame: 24 months
Evaluate host immunogenicity to SC262
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gerecitano, MD, PhD study director
Sana Biotechnology, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC262 in people with Non Hodgkin's Lymphoma and Large B-cell Lymphoma, run by Sana Biotechnology at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety and tolerability of SC262 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.