Trials / Completed
CompletedNCT04317885
A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in NHL Subjects
A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Relapsed or Refractory NHL Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR039 in treatment of relapsed or refractory NHL patients
Detailed description
This study plans to enroll 25 patients to assess the safety and efficacy of C-CAR039. Subjects who meet the eligibility criteria will receive a single dose of C-CAR039 injection. The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Bridging (if needed), Baseline, lymphodepletion, C-CAR039 infusion, and Follow-up Visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Prizloncabtagene Autoleucel | Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously |
Timeline
- Start date
- 2019-11-05
- Primary completion
- 2023-06-30
- Completion
- 2023-12-30
- First posted
- 2020-03-23
- Last updated
- 2025-05-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04317885. Inclusion in this directory is not an endorsement.