Actively Recruiting
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
Led by University Hospital Heidelberg · Updated on 2024-07-29
68
Participants Needed
2
Research Sites
486 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years and older) with confirmed CD19+ ALL, CLL, DLBCL, FL, or MCL
- Relapsed or refractory disease with measurable disease or minimal residual disease (MRD) at enrollment
- Life expectancy of at least 12 weeks
- ECOG performance status of 2 or less
- Adequate organ function including kidney, liver, lung, heart, and blood counts
- Women of child-bearing potential and all males must agree to use effective contraception for one year after therapy
- Ability to understand the trial and provide informed consent
- Children and adolescents (over 3 and under 18 years) with CD19+ ALL meeting similar relapse/refractory criteria and organ function requirements
- Lansky performance status 50 or higher for children under 16 years
- Written informed consent obtained from patient or legal representative
You will not qualify if you...
- Use of immunosuppressive medication beyond specified limits at time of therapy
- Bridging or maintenance chemo- or immunotherapy not stopped at least 2 weeks before leukapheresis (except allowed between leukapheresis and lymphodepletion)
- Acute or chronic graft-versus-host disease (GvHD)
- Uncontrolled active hepatitis B or C infection
- HIV positive status
- Uncontrolled life-threatening bacterial, viral, or fungal infection
- Severe concomitant diseases such as uncontrolled hypertension, heart failure NYHA III-IV, uncontrolled diabetes or hyperlipidemia
- Recent unstable angina or myocardial infarction within 3 months
- Pregnant or nursing women
- Intolerance to components of the cell product
- Active CNS involvement with CNS 3 status at screening
- Participation in another clinical trial at screening
- Previous or concurrent malignancy except for specified adequately treated or in remission cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Hospital Heidelberg
Heidelberg, Germany
Actively Recruiting
2
University Hospital Heidelberg
Heidelberg, Germany
Actively Recruiting
Research Team
P
Prof. Dr. Michael Schmitt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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