Actively Recruiting
Study on Safety of CD19 CAR-T Cells in Adults With Relapsed or Refractory AML Expressing CD19
Led by University Hospital, Lille · Updated on 2025-12-05
5
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Relapsed or refractory acute myeloid leukemia (AML) especially with the t(8;21) translocation is difficult to treat and often leads to poor outcomes. This form of AML abnormally expresses the CD19 antigen on cancer cells and stem cells, providing a potential target for new therapies. Patients with this subtype who relapse after intensive chemotherapy have limited options, prompting research into innovative treatments like anti-CD19 CAR-T cell therapy. The study evaluates the safety of anti-CD19 CAR-T cell therapy in adults with relapsed or refractory AML expressing CD19. Patients will receive conditioning chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of genetically modified CAR-T cells designed to target CD19 on their leukemia cells. The CAR-T cells are produced using a semi-automated bioreactor in an academic setting. This phase I trial focuses on patients for whom no curative alternatives exist. Participants will be closely monitored after infusion, with assessments including bone marrow biopsies and molecular tests to evaluate treatment response and remission. Safety is tracked by observing side effects like cytokine release syndrome and neurological symptoms. The study measures survival without disease progression one month after treatment and follows patients up to a couple of years to assess CAR-T cell persistence, response duration, and overall outcomes.
CONDITIONS
Brief Title
Study Investigating the Safety of CD19 CAR-T Cells in Relapsed/Refractory AML Expressing CD19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Diagnosis of AML with CD19 expression on at least 70% of leukemia blasts by flow cytometry
- Relapsed or refractory AML defined as primary refractory, secondary refractory after salvage treatment, or post-transplant relapse
- No accessible targeted therapy previously used
- ECOG performance status less than 2
- Life expectancy greater than 2 months
- Brain MRI showing no central nervous system involvement
- Stable toxicities from prior therapy at Grade 1 or less (except for non-significant ones like alopecia)
- Platelet count at least 30,000/uL
- Absolute lymphocyte count at least 200/uL
- Creatinine clearance at least 40 mL/min
- Serum liver enzymes (ALT/AST) less than or equal to 2.5 times upper limit of normal
- Total bilirubin less than or equal to 1.5 mg/dL (except Gilbert's syndrome)
- Cardiac ejection fraction at least 45%
- No clinically significant ECG abnormalities
- No significant pleural effusion
- Baseline oxygen saturation over 92% on room air
- Female participants of childbearing potential must have negative pregnancy test and agree to effective contraception or true abstinence during study and for 1 year after
- Female participants not of childbearing potential or surgically sterile may enroll
- Male participants must agree to true abstinence or use condoms with females of childbearing potential for 1 year after infusion
- Agree to abstain from breastfeeding during study and for 1 year after infusion
You will not qualify if you...
- Unable to provide informed consent
- AML without CD19 expression
- History of other malignancies except certain skin cancers or carcinoma in situ unless disease-free for at least 3 years
- Prior CD19-targeted therapy or CAR-T/genetically modified T cell therapy
- Uncontrolled or IV antimicrobial requiring infections
- History of HIV or HTLV1 infection
- Active or chronic hepatitis B or C infection unless cleared
- Malignant cells detected in cerebrospinal fluid or brain metastases
- History or presence of non-malignant central nervous system disorders like seizures or dementia
- Under legal guardianship or curatorship
- Pregnant or breastfeeding females or planning pregnancy
- Hypersensitivity to study drug or excipients
- Contraindications to lymphodepleting chemotherapy
- No medical insurance coverage
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 - Short period prior to CAR-T cell infusion
Participants receive cyclophosphamide and fludarabin conditioning before CAR-T cell infusion.
1 to 2 visits (in-person)
Duration - Single infusion with follow-up for immediate effects
Participants receive a target dose of autologous, genetically modified, anti-CD19 CAR-T cells.
1 infusion visit and multiple visits for monitoring during the first month
Duration - Up to 2 years
Participants are monitored for safety, CAR-T cell persistence, response, and survival over up to 2 years.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
CHU de Lille
Lille, France, 59000
Actively Recruiting
Research Team
I
Ibrahim Yakoub-Agha, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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