Trials / Unknown
UnknownNCT03156101
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in R/R ALL and Lymphoma Subjects
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Acute Lymphoblastic Leukemia and Lymphoma Subjects
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Shenzhen BinDeBio Ltd. · Industry
- Sex
- All
- Age
- 4 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.
Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia
- Refractory B-cell Acute Lymphoblastic Leukemia
- Relapsed／Refractory B-cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BinD19 | Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration. |
Timeline
- Start date
- 2017-03-02
- Primary completion
- 2021-05-30
- Completion
- 2021-12-30
- First posted
- 2017-05-17
- Last updated
- 2021-02-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03156101. Inclusion in this directory is not an endorsement.