Clinical trial · Interventional
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)
NCT05878184CI-TRIAL-00096140active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SC291 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SC291 Plus Chemotherapy Regimen
- description
- A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291
- interventionNames
- Drug: SC291
Primary outcomes (1)
- measure
- Evaluate safety and tolerability of SC291
- timeFrame
- 24 months
- description
- Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Secondary outcomes (5)
- measure
- Evaluate preliminary anti-tumor activity of SC291
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.