Trials / Recruiting
RecruitingNCT05464719
A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
Detailed description
Primary Objective: -To evaluate the efficacy of lonca as consolidation therapy in patients with relapsed or refractory LBCL who achieve PR after CAR T-cell therapy. Secondary Objectives: -To evaluate safety and tolerability of lonca as consolidation therapy in patients with relapsed or refractory LBCL who achieve PR after CAR T-cell therapy. Exploratory Objective: -To determine the pharmacodynamic effects and investigate biomarkers of response and resistance of this novel consolidation therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Loncastuximab Tesirine | Given by IV |
Timeline
- Start date
- 2022-09-23
- Primary completion
- 2030-01-30
- Completion
- 2030-01-30
- First posted
- 2022-07-19
- Last updated
- 2026-01-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05464719. Inclusion in this directory is not an endorsement.