Trials / Recruiting
RecruitingNCT05054257
CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Institute of Hematology and Blood Transfusion, Czech Republic · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
Detailed description
This is an open-label, single arm study on up to 24 adult subjects with refractory or relapsed CD19+ Non-Hodgkin's Lymphoma or B-ALL. Following lymphodepleting conditioning regimen, the patients will receive a single dose of autologous CAR19 T lymphocytes provided by the sponsor´s manufacturing facility. CART19 dose will be escalated in consecutive patients using accelerated titration design in order to establish recommended CART19 dose for further study, which will be either Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD), whichever is reached first.
Conditions
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
- Non-Hodgkin's Lymphoma Refractory
- Non-Hodgkin's Lymphoma, Relapsed
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Autologous CAR19 T lymphocytes | First-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL |
Timeline
- Start date
- 2021-06-02
- Primary completion
- 2025-06-01
- Completion
- 2025-12-12
- First posted
- 2021-09-23
- Last updated
- 2025-01-06
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT05054257. Inclusion in this directory is not an endorsement.