Actively Recruiting
A Phase II Non-inferiority Study Comparing Point-of-care Produced CAR T-cell to Commercial CAR T-cells in Patients with Relapsed/refractory Non-Hodgkin Lymphoma
Led by University Medical Center Groningen · Updated on 2024-09-23
300
Participants Needed
7
Research Sites
104 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
Researchers are comparing the feasibility and clinical effectiveness of locally made CD19-directed CAR T-cells (called ARI-0001) with commercially produced CAR T-cells, such as axicabtagene ciloleucel, in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL). This phase II study focuses on improving treatment accessibility and quality by addressing delays and quality issues caused by centralized production and cryopreservation in current therapies. The study involves two treatment groups: one receiving ARI-0001 CAR T-cells produced on-site using the CliniMACS Prodigy device, which takes about 7-12 days and infuses fresh cells without cryopreservation; the other receives standard commercial CAR T-cells like axicabtagene ciloleucel, which require longer production times and cryopreservation. Both treatments use a single target dose of approximately 2.0 x 10^6 CAR T-cells per kilogram of body weight. Participants will be closely monitored for up to 60 months after infusion, with assessments including progression-free survival, overall response rate, CAR T-cell expansion and persistence, adverse events, and quality of life measures. Various laboratory tests and patient questionnaires will be conducted at multiple time points up to two years post-infusion. The study aims to evaluate the clinical outcomes, safety, and production quality of the two CAR T-cell therapies over a long follow-up period.
CONDITIONS
Brief 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 Diffuse Large B-cell Lymphoma (DLBCL) or related subtypes according to WHO 2016 classification
- Relapsed or refractory after at least 2 lines of systemic therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0 to 2
- Secondary central nervous system involvement allowed if no symptoms affecting assessment
- Estimated life expectancy greater than 3 months
- Willingness to use birth control during and for four months after treatment if of child-bearing potential
- Ability to provide signed informed consent
- Capable of giving informed consent
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 central nervous system lymphoma
- Untreated or uncontrolled 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 in past 12 months
- Stroke or cerebrovascular accident within past 12 months
- Unstable neurological deficits
- Autoimmune central nervous system diseases
- Active systemic autoimmune disease needing immunosuppressive therapy
- CNS disease that interferes with neurotoxicity evaluation or baseline dementia
- Active systemic fungal, viral, or bacterial infection
- Heart failure with New York Heart Association class 2 or higher or low heart function
- Resting oxygen saturation less than 92% on room air
- Severe liver dysfunction unless related to lymphoma or Gilbert disease
- Kidney function with GFR less than 40 mL/min
- Pregnant or breastfeeding women
- Active other cancer needing treatment
- Use of prolonged systemic immunosuppressives except low-dose prednisolone
- Severe allergy to drugs used in lymphodepletion or treatment
- Conditions hampering study compliance or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 12 days for CAR T-cell production plus infusion, with follow-up assessments extending up to 60 months
Participants receive infusion with either point-of-care produced CAR T-cells or commercially produced CAR T-cells as part of their treatment for relapsed or refractory Diffuse Large B-cell Lymphoma.
1 infusion visit followed by multiple follow-up visits at 4 weeks, 12 weeks, 6, 12, and 24 months after infusion
Duration - Up to 60 months following CAR T-cell infusion
Participants are monitored for safety, response, and long-term outcomes after CAR T-cell infusion.
Regular follow-up visits at 4 weeks, 12 weeks, 6, 12, and 24 months, with additional assessments up to 60 months
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
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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