A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies (NCT05588440) | Clinical Trial Compass
TerminatedPhase 1/2
A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies
Stopped: Based on the available clinical data and capital requirements for continued development, the Company has decided to terminate this study.
United States9 participantsStarted 2023-05-09
Plain-language summary
This is a Phase 1/2 study to investigate the safety and efficacy of the CAR-T therapy, ONCT-808, in patients with relapsed/refractory (R/R) aggressive B cell malignancies.
Who can participate
Age range
18 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.
Key Inclusion Criteria:
* Over 18 years old
* Histologically confirmed aggressive B-cell NHL, including:
* MCL, with diagnosis confirmed by cyclin D1 overexpression or evidence of t (11;14) translocation
* LBCL, including:
* DLBCL NOS
* Primary mediastinal LBCL
* High-grade BCL
* DLBCL arising from follicular lymphoma
* Follicular lymphoma grade 3B
* Richter's syndrome
* Availability of archival tissue for immunohistology, or willing to undergo baseline biopsy if not available
* R/R with no available therapy. Subject must have:
* Received prior systemic therapy that has included an alkylating agent, anthracycline, and an anti-CD20 mAb
* Received and progressed after autologous hematopoietic stem cell transplant (HSCT) or is ineligible for or has refused to receive HSCT
* Received prior approved CD19 CAR T-cell therapy or is ineligible for or has refused CD19 CAR-T
* Minimum washout period between previous systemic therapy and leukapheresis includes:
* Chemotherapy: at least 14 days or 5 half-lives, whichever is shorter
* Autologous HSCT: at least 3 months
* CD19 CAR T-cell therapy: at least 6 months
* ≥1 measurable lesion per Lugano criteria (Cheson, 2014)
* Subject has Fluorodeoxyglucose (FDG)-avid disease.
* Subject has an ECOG performance status of 0 or 1.
* Subject has adequate organ function:
* ALC ≥100/uL
* ANC ≥1000/uL (≥500/uL if due to lymphoma; growth factors allowed)
* Hgb ≥8 g/dL (transfusion allowed)
* Platele…
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.
What they're measuring
1
To Evaluate the Incidence of Dose Limiting Toxicities (DLT)
Timeframe: Up to 28 days after the one-time infusion of ONCT-808