Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT) (NCT05878184) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
United States, Australia16 participantsStarted 2023-05-02
Plain-language summary
SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.