Trials / Unknown
UnknownNCT04037566
CRISPR (HPK1) Edited CD19-specific CAR-T Cells (XYF19 CAR-T Cells) for CD19+ Leukemia or Lymphoma.
A Safety Study of Autologous T Cells Engineered to Target CD19 and CRISPR Gene Edited to Eliminate Endogenous HPK1 (XYF19 CAR-T Cells) for Relapsed or Refractory Haematopoietic Malignancies.
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Xijing Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-human trial proposed to test CD19-specific CAR-T cells with edited endogenous HPK1 (XYF19 CAR-T cells) in patients with relapsed or refractory CD19+ leukemia or lymphoma. This is an investigational study designed as a single-center, open-label and single-arm clinical trial.
Conditions
- Leukemia Lymphocytic Acute (ALL) in Relapse
- Leukemia Lymphocytic Acute (All) Refractory
- Lymphoma, B-Cell
- CD19 Positive
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | XYF19 CAR-T cell | Autologous T cells engineered to specify CD19 transduced with a lentiviral vector and electroporated with CRISPR guide RNA to disrupt expression of endogenous HPK1 administered by IV injection. |
| DRUG | Cyclophosphamide | A cytotoxic chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells. |
| DRUG | Fludarabine | A chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells. |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2021-08-01
- Completion
- 2024-08-01
- First posted
- 2019-07-30
- Last updated
- 2019-07-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04037566. Inclusion in this directory is not an endorsement.