Non Hodgkin LymphomaPhase 1NCT05878184
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
A Phase 1 study testing SC291 in people with Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Sana Biotechnology at 10 sites in 2 countries.
Trial summary
SC291-101 is a Phase 1 study to evaluate SC291 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 Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- SC291
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 2 May 2023to 4 Nov 2038
- 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 subjects aged 18-80 years at the time of signing informed consent.
- Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including:
- Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise - - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B
- Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B)
- Marginal zone lymphoma (dose escalation only)
- Mantle cell lymphoma (dose escalation only)
Show all 11Show fewer
- CLL or SLL
- Relapsed/refractory disease after at least 2 prior systemic regimens per standard of care or after autologous stem cell transplant
- ECOG performance status of 0 or 1.
- At least one measurable lesion per Lugano Classification (NHL); CLL subjects must meet iwCLL treatment criteria
- Life expectancy ≥12 weeks
Who cannot join
- Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required)
- History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
- Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics)
- Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time).
- Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >20 mg/day prednisone or equivalent).
- History or presence of cardiac or CNS disorders as defined in the protocol
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Northside Hospital
Atlanta, Georgia, 30342
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
University of Kansas Medical Center
Fairway, Kansas, 66205
MD Anderson Cancer Center
Houston, Texas, 77030
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford Cancer Institute
Palo Alto, California, 94304
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official title: A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)
SC291-101 is a Phase 1 study to evaluate SC291 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 SC291 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with NHL or CLL who have received two or more prior systemic treatments per standard of care (or after autologous stem cell transplant [ASCT] for NHL). This study will be conducted in 2 parts. Phase 1a: dose finding using a 3+3 design in subjects with NHL or CLL. Phase 1b: dose expansion to further evaluate safety and efficacy at the RP2D in subjects with LBCL and CLL.
- Conditions
- Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- Being tested
- SC291
- Keywords
- Large B cell lymphoma, CAR T Cell Therapy, Mantle cell lymphoma, Indolent follicular lymphoma, Marginal zone lymphoma, High-grade B cell lymphoma, Primary mediastinal B cell lymphoma, Diffuse large B cell lymphoma, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Allogeneic, Hypoimmune, CD19
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, 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.
SC291Drug
Also called Cyclophosphamide, Fludarabine
SC291 is an allogeneic CAR-T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| SC291 Plus Chemotherapy Regimen | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291 Receives: Drug: SC291 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability of SC291
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 SC291
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 SC291
Cellular kinetics-related parameters evaluated by CAR T cell copy number
Measured: 24 months
Evaluate cellular kinetics and persistence of SC291
Cellular kinetics related peak (Cmax) in peripheral blood
Measured: 24 months
Evaluate cellular kinetics and persistence of SC291
Area under the concentration time curve (AUC) in peripheral blood
Measured: 24 months
Evaluate host immunogenicity to SC291
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 posted26 May 2023
- Study start2 May 2023
- Primary completion4 Nov 2025 (estimated)
- Study completion4 Nov 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin 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
- 16 participants (actual)
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
- NCT05878184
- Sponsor's protocol ID
- SC291-101
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)
- ClinicalTrials.gov ID
- NCT05878184
- Acronym / sponsor ID
- SC291-101
- Conditions
- Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- Keywords
- Large B cell lymphoma, CAR T Cell Therapy, Mantle cell lymphoma, Indolent 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
- 16 participants (actual)
- Lead sponsor
- Sana BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 4 Nov 2025 (estimated)
- Study completion
- 4 Nov 2038 (estimated)
- First posted
- 26 May 2023 (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.
SC291-101 is a Phase 1 study to evaluate SC291 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 SC291 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with NHL or CLL who have received two or more prior systemic treatments per standard of care (or after autologous stem cell transplant [ASCT] for NHL). This study will be conducted in 2 parts. Phase 1a: dose finding using a 3+3 design in subjects with NHL or CLL. Phase 1b: dose expansion to further evaluate safety and efficacy at the RP2D in subjects with LBCL and CLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC291 Plus Chemotherapy Regimen | Experimental | Drug: SC291A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects aged 18-80 years at the time of signing informed consent.
- Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including:
- Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise - - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B
- Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B)
- Marginal zone lymphoma (dose escalation only)
Key exclusion criteria (6 listed)
- Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required)
- History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
- Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics)
- Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time).
- Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >20 mg/day prednisone or equivalent).
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 |
|---|---|---|
| SC291Also: Cyclophosphamide, FludarabineSC291 is an allogeneic CAR-T cell therapy | Drug | SC291 Plus Chemotherapy Regimen |
Primary outcome
Evaluate safety and tolerability of SC291
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 SC291
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC291
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC291
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC291
Time frame: 24 months
Evaluate host immunogenicity to SC291
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 2 Oct 2025.
- Individual participant dataSharing planned: No
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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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC291 in people with Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Sana Biotechnology at 10 sites in 2 countries.
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 11 inclusion and 6 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia. 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 SC291 (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 2 Oct 2025.