Trials / Unknown
UnknownNCT03720457
Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory CD19-positive Lymphoma.
A Phase I Clinical Trial of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Hrain Biotechnology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Detailed description
Participants with relapsed/refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma can participate if all eligibility criteria are met.Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws.Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Human CD19 targeted T Cells Injection | Autologous genetically modified anti-CD19 CAR transduced T cells |
Timeline
- Start date
- 2018-11-13
- Primary completion
- 2021-10-01
- Completion
- 2023-10-01
- First posted
- 2018-10-25
- Last updated
- 2021-08-31
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03720457. Inclusion in this directory is not an endorsement.