CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 68 target
Drug / intervention
CD19.CAR T Cells +2 morebiological
Likely dose
Fludarabine 30 mgfrom record
Key inclusion· 15
  • ✓Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL
  • ✓Adults ≥18 years or children >3 to <18 years
  • ✓Relapsed or refractory disease with CD19 expression confirmed on malignant cells in relapse
  • ✓Measurable disease/MRD at time of enrollment
Key exclusion· 15
  • ✕Immunosuppressive medication >30mg prednisolone/day equivalent (adults) or >0.5mg/kg/day (children)
  • ✕Bridging/maintenance chemo- or immunotherapy not stopped ≥2 weeks prior to leukapheresis
  • ✕Intrathecal chemotherapy during lymphodepletion until 14 days after CAR T cell infusion
  • ✕DLI not completed >6 weeks prior to CAR T cell infusion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03676504
NCT03676504Phase 2RecruitingOn TrackUpdated 23mo ago
Long Recruiting
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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

University Hospital Heidelberg·interventional·Posted Sep 18, 2018·Updated Jul 29, 2024

In Brief

A Phase 2 clinical trial evaluating CD19.CAR T Cells, Fludarabine, and 1 other intervention for Acute Lymphoblastic Leukemia, Adult and 5 related conditions. Currently recruiting, targeting 68 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, Pediatric, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma
CountriesGermany
Collaborators--

Timeline

Phase 2Recruiting
2019202020212022202320242025202620272028
First PostedSep 18, 2018
Enrollment StartSep 7, 2018
Primary CompletionDec 31, 2026
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 7.8 years agoPrimary completion in 6 months

Interventions

CD19.CAR T Cellsbiological

Dose 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

Fludarabinedrug

3 days of fludarabine 30 mg/m\^2/day

Cyclophosphamidedrug

3 days of cyclophosphamide 500 mg/m\^2/day