Trials / Not Yet Recruiting
Not Yet RecruitingNCT07298590
An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK in the Treatment of Relapsed and Refractory IgG4-related Disease
An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK (KN5601) in the Treatment of Relapsed and Refractory IgG4-related Disease (IgG4-RD)
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Changhai Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19/BCMA CAR NK cells (KN5601) in patients with IgG4 related diseases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19/BCMA CAR NK | Patients will receive Fludarabine and Cyclophosphamide on day -5, -4, and -3. Multiple doses of CD19/BCMA CAR NK cells will infused using the dose-escalation strategy. |
Timeline
- Start date
- 2025-12-30
- Primary completion
- 2028-06-26
- Completion
- 2028-12-26
- First posted
- 2025-12-23
- Last updated
- 2025-12-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07298590. Inclusion in this directory is not an endorsement.