Actively Recruiting
Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL
Led by University Medical Center Groningen · Updated on 2024-09-23
300
Participants Needed
7
Research Sites
267 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
S
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R/R) DLBCL.
CONDITIONS
Official Title
Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed DLBCL or associated subtypes as defined by WHO 2016 classification
- Relapsed or refractory after at least 2 lines of systemic therapy
- Age 18 years or older
- ECOG performance status 0 to 2
- Secondary CNS involvement allowed if no symptoms hampering ICANS assessment
- Estimated life expectancy greater than 3 months excluding lymphoma
- Willingness to use birth control from enrollment and for four months after preparative regimen
- Ability to provide signed informed consent and capable of consenting
You will not qualify if you...
- Absolute neutrophil count less than 1.0 x 10^9/L
- Platelet count less than 50 x 10^9/L
- Absolute lymphocyte count less than 0.1 x 10^9/L
- Primary CNS lymphoma
- Untreated or active hepatitis B or C infection
- Active HIV infection with detectable viral load or low CD4 count
- History of seizures or use of anti-seizure medication within past 12 months
- History of stroke within prior 12 months
- Unstable neurological deficits
- Autoimmune CNS diseases or systemic autoimmune disease requiring immunosuppression
- CNS disease impairing neurotoxicity evaluation or baseline dementia
- Active systemic fungal, viral, or bacterial infection
- Heart failure NYHA class 2 or higher or low left ventricular ejection fraction
- Resting oxygen saturation below 92% on room air
- Severe liver dysfunction not related to lymphoma
- Kidney function with GFR below 40 mL/min
- Pregnant or breastfeeding women
- Active other cancers requiring treatment
- Need for prolonged systemic immunosuppressive therapy except low-dose prednisolone
- History of severe immediate allergic reaction to drugs used in study protocol
- Psychological, social, or geographic conditions that may impair study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
NL-Amsterdam-AMC
Amsterdam, Netherlands
Actively Recruiting
2
NL-Groningen-UMCG
Groningen, Netherlands
Actively Recruiting
3
NL-Leiden-LUMC
Leiden, Netherlands
Actively Recruiting
4
NL-Maastricht-MUMC
Maastricht, Netherlands
Actively Recruiting
5
NL-Nijmegen-RADBOUDUMC
Nijmegen, Netherlands
Actively Recruiting
6
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
Actively Recruiting
7
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
Actively Recruiting
Research Team
T
T. (Tom) van Meerten
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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