NCT03676504 Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
| NCT ID | NCT03676504 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital Heidelberg |
| Condition | Acute Lymphoblastic Leukemia, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2018-09-07 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion 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 apart) with confirmed CD19 expression on malignant cells in relapse * Any relapse after allogeneic stem cell transplantation (alloSCT) (≥ 6 months from alloSCT at time of CAR T cell infusion) OR * Any relapse failing to achieve an MRD level of \< 10\^-3 after ≥ 2 lines of treatment OR * Primary refractory as defined by not achieving a complete remission (CR) after ≥ 2 lines of treatment * CLL/NHL: Confirmed CD19+ CLL/NHL (including CLL, DLBCL, FL or MCL) with * CLL in need of treatment with: 1. Early relapse (within 2 years) after end of chemoimmunotherapy or chemoimmunotherapy refractoriness plus failure or intolerance of both Bruton's tyrosine kinase
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