Trials / Recruiting
RecruitingNCT04836507
Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients
An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 91 (estimated)
- Sponsor
- Curocell Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma.
Conditions
- Relapsed Large B-cell Lymphoma
- Refractory Large B-cell Lymphoma
- Diffuse Large B-cell Lymphoma (DLBCL)
- Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- High-grade B-cell Lymphoma
- Transformed Follicular Lymphoma (TFL)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CRC01 | A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg. |
| DRUG | Fludarabine | Administered according to package insert |
| DRUG | Cyclophosphamide | Administered according to package insert |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2023-05-01
- Completion
- 2028-02-01
- First posted
- 2021-04-08
- Last updated
- 2021-05-03
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04836507. Inclusion in this directory is not an endorsement.