Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL
The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r/r) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock
| Condition(s) | Non-hodgkin Lymphoma,B Cell |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r/r) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock out endogenous receptor α constant (TRAC), human leukocyte antigen (HLA)-A/B, CIITA, and programmed death 1 (PD-1) genes simultaneously in T cells from healthy donors, and integrated the STAR molecule into the TRAC locus using adenovirus associated virus. This strategy can reduce graft-versus-host-disease (GvHD) toxicity and host-versus-graft response, decrease the sensitivity of STAR T cells to immunosuppressive signals, and improve their anti-tumor activity. In this single |
| Who can participate | Inclusion Criteria: 1. Age 18-75 (inclusive). 2. Patients with histologically confirmed CD19-positive B-cell NHL, including the following types defined by the World Health Organization (WHO) 2016: * Diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), including activated B-cell type (ABC) / germinal center B-cell Type (GCB); * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL); * Transformed follicular lymphoma (TFL); * High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL); * Follicular lymphoma (FL); * Mantle cell lymphoma (MCL) \[pathologically confirmed, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1\]; * Marginal zone lymphoma (MZL), including nodal or splenic m |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Chinese PLA General Hospital |
| Locations | Beijing, Beijing Municipality, China; Beijing, China |
| Start date | 2024-03-20 |
| NCT ID | NCT06321289 |
| Official listing | https://clinicaltrials.gov/study/NCT06321289 |