Trials / Active Not Recruiting
Active Not RecruitingNCT04718883
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.
Detailed description
This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment. R/R MCL patients will be enrolled in dose level of 1.0 x 10\^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19-targeted Chimeric Antigen Receptor (CAR) T Cells | JWCAR029 will be administered at dose level: 1 x 10\^8 CAR+T cells |
Timeline
- Start date
- 2021-01-13
- Primary completion
- 2023-10-25
- Completion
- 2028-08-07
- First posted
- 2021-01-22
- Last updated
- 2023-11-24
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04718883. Inclusion in this directory is not an endorsement.