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HR001 in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
NCT05436223Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2021
- Primary completion
- Aug 2024
- Countries
- 1
- Sponsor
- Shanghai HRAIN Biotechnology
- Modality
- Gene Editing, Gene Silencing, CAR-T Cells
- Drugs
- DASH CD19 CAR-T
- Conditions
- B-cell non-Hodgkin lymphoma
01
Overview
Phase 2, open-label, single-arm trial of DASH CD19 CAR-T in B-cell non-Hodgkin lymphoma, sponsored by Shanghai HRAIN Biotechnology. Primary endpoint: Overall response rate at 3 months. Started Aug 2021; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
HR001 Arm
Single arm receiving conditioning followed by HR001 infusion.
03
Who it enrols
Adult patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (DLBCL, PMBCL, TFL, HGBCL) who have failed at least two prior lines of therapy or relapsed after stem cell transplantation.
04
Endpoints
Primary
Overall response rate
Secondary
Duration of remission
Progression-free Survival
Overall Survival
Disease control rate
Safety evaluation
Maximum CAR level in peripheral blood
Time to peak CAR level in blood
28-day Area under the curve of the CAR level in blood
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