OncRef

Clinical Trial: NCT03676504

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

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:University Hospital Heidelberg
Information Provided By:University Hospital Heidelberg
Last Update Posted:2024-07-29

Study Overview

Brief 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.

Official Title

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

Conditions

Acute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, Pediatric, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma

Intervention / Treatment

  • Biological: CD19.CAR T Cells
  • Drug: Fludarabine
  • Drug: Cyclophosphamide

Other Study ID Numbers

  • HD-CAR-1

Start Date (Actual)

2018-09-07

Primary Completion Date (Estimated)

2026-12-31

Study Completion Date (Estimated)

2027-12-31

Enrollment (Estimated)

68

Study Type

Interventional

Phase

Phase 1, Phase 2