Trials / Active Not Recruiting
Active Not RecruitingNCT05757700
Study of 19(T2)28z1xx TRAC-Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Lymphoma
A Phase I Study of T-cell Receptor Alpha Constant (TRAC) Locus Integrated CD19-Targeted 19(T2)28z1xx Chimeric Antigen Receptor (CAR) Modified T Cells in Adult Patients With CD19+ Relapsed or Refractory Large B-Cell Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to evaluate if study therapy, 19(T2)28z1xx TRAC-chimeric antigen receptor (CAR) T cells, may be an effective treatment for people with relapsed/refractory B-cell lymphoma. Researchers will also evaluate if this study therapy is safe, and to look for the highest dose that causes few or mild side effects in participants.
Conditions
- B-Cell Lymphoma
- Large B-cell Lymphoma
- DLBCL, Nos Genetic Subtypes
- High-grade B Cell Lymphoma
- Mediastinal Large B-cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 19(T2)28z1xx TRAC T cell | Participants will be treated with escalating doses of modified T cells. Dose level -1: 3 x 10\^6 Dose level 1: 10 x 10\^6 Dose level 2: 30 x 10\^6 Dose level 3: 100 x 10\^6 |
Timeline
- Start date
- 2023-02-23
- Primary completion
- 2026-02-23
- Completion
- 2026-02-23
- First posted
- 2023-03-07
- Last updated
- 2025-04-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05757700. Inclusion in this directory is not an endorsement.