NCT05878184Active, not recruitingPhase 1
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 28 Apr 2023
- Start date
- 2 May 2023
- Primary completion date
- 4 Nov 2025
- Lead sponsor
- Sana Biotechnology
- Diseases
- Diffuse large B-cell lymphoma, Follicular lymphoma, Mantle cell lymphoma, Chronic lymphocytic leukaemia
- NCT number
- NCT05878184
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 2 May 2023 to the primary completion date, 4 Nov 2025
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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).
Other illness
- History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
- 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
Who the study is looking for
- 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)
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Linear Clinical Research Ltd Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Northside Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Stanford Cancer Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.