Trials / Not Yet Recruiting
Not Yet RecruitingNCT06559644
Hema-NeoTIL01 Cell Infusion Therapy in Relapsed/Refractory Acute Leukemia
Assessment of the Safety and Efficacy of Hema-NeoTIL01 Cell Infusion Therapy in Relapsed/Refractory Acute Leukemia: A Single-Arm, Open-Label, Prospective Study
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of autologous tumor-specific T cells, known as Hema-NeoTIL0 in treating relapsed/refractory B-ALL/AML.
Detailed description
Primary Objective: To assess the safety of Hema-NeoTIL01 in the treatment of relapsed/refractory acute leukemia (B-ALL/AML). Secondary Objective: To evaluate the efficacy of Hema-NeoTIL01 in relapsed/refractory acute leukemia (B-ALL/AML).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Hema-NeoTIL01 | Patients will receive intravenous infusion of Hema-NeoTIL01, which is a highly specific tumor infiltrating lymphocyte (TIL) product derived from patients' bone marrow or peripheral blood, expanded ex vivo through antigen presentation. |
Timeline
- Start date
- 2024-09-01
- Primary completion
- 2026-09-01
- Completion
- 2026-12-01
- First posted
- 2024-08-19
- Last updated
- 2024-08-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06559644. Inclusion in this directory is not an endorsement.