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

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 lymphode

Trial Details

NCT ID
NCT03676504
Phase
PHASE1 / PHASE2
Sponsor
University Hospital Heidelberg
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • CD19.CAR T Cells
  • Fludarabine
  • Cyclophosphamide
Locations (sample)
  • Heidelberg, Germany|49.40768,8.69079
  • Heidelberg, Germany|49.40768,8.69079

Key Eligibility Criteria

  • Stratum I/II (Adults):
  • Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years
  • ALL (Ph+ and Ph-): Confirmed CD19+ ALL by cytology and flow cytometry (FACS) AND
  • Relapsed or refractory disease (including "molecular relapse" with minimal residual disease (MRD) levels \> 10\^-3 at two occasions \> 2 weeks apar…

For full eligibility, visit ClinicalTrials.gov.

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