Trials / Unknown
UnknownNCT02892695
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 3 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant.
Detailed description
The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant. In addition, some patients who enroll to other CD19-CAR-T cell therapy trials might be eligible for this trial if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed.
Conditions
- Acute Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia
- Follicular Lymphoma
- Mantle Cell Lymphoma
- B-cell Prolymphocytic Leukemia
- Diffuse Large Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | anti-CD19 CAR-NK cells | The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD19 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD19. |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-09-01
- Completion
- 2019-09-01
- First posted
- 2016-09-08
- Last updated
- 2016-12-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02892695. Inclusion in this directory is not an endorsement.