Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03676504

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
68 (estimated)
Sponsor
University Hospital Heidelberg · Academic / Other
Sex
All
Age
3 Years
Healthy volunteers
Not accepted

Summary

Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20\^7 transduced cells/m\^2) after lymphodepletion with fludarabine and cyclophosphamide.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCD19.CAR T CellsDose Level 1: 1×10\^6 transduced cells/m\^2; Dose Level 2: 5×10\^6 transduced cells/m\^2; Dose Level 3: 20×10\^6 transduced cells/m\^2; Dose Level 4: 5x10\^7 transduced cells/m\^2; Dose Level 5: 10x10\^7 transduced cells/m\^2; Dose Level 6: 20x10\^7 transduced cells/m\^2
DRUGFludarabine3 days of fludarabine 30 mg/m\^2/day
DRUGCyclophosphamide3 days of cyclophosphamide 500 mg/m\^2/day

Timeline

Start date
2018-09-07
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2018-09-18
Last updated
2024-07-29

Locations

2 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT03676504. Inclusion in this directory is not an endorsement.