Trials / Active Not Recruiting
Active Not RecruitingNCT06093841
Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL
Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL: a Single-arm, Multicenter, Open, Phase II Study
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.
Detailed description
This is an open-label, multicenter, Phase 2 study to determine the antitumor activity, PK, and safety of JWCAR029(Relmacabtagene autoleucel ) in subjects who have relapsed within 12 months from, or are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.
Conditions
- Lymphoma, Large B-Cell, Diffuse
- Follicular Lymphoma Grade 3B
- High-grade B-cell Lymphoma
- Mediastinal B-Cell Diffuse Large Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Relmacabtagene Autoleucel | A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells |
| DRUG | Fludarabine | Administered according to package insert |
| DRUG | Cyclophosphamide | Administered according to package insert |
Timeline
- Start date
- 2023-11-03
- Primary completion
- 2024-01-21
- Completion
- 2029-11-04
- First posted
- 2023-10-23
- Last updated
- 2025-02-11
Locations
13 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06093841. Inclusion in this directory is not an endorsement.