BridgeMD
Tests treatment safety and results for Relapsed Adult AML
Official title Study Investigating the Safety of CD19 CAR-T Cells in Relapsed/Refractory AML Expressing CD19
ClinicalTrials.gov ID: NCT06649227
What this study is testing
What is CAR-T cell therapy?
CAR-T cell therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed adult aml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Refractory/Relapsed (R/R) acute myeloid leukemia (AML) is associated with a dis-mal prognosis. In some subsets of AML such as AML driven by the t(8;21) translocation, leading to the RUNX1-RUNX1T1 (AML1-ETO) fusion transcript expression, CD19 B-cell antigen is aberrantly expressed on malignant blasts in around 80 % of cases.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is ≥ 18 years of age at the time of signing the informed consent form,
- Patient with AML that expresses CD19 by Flow-cytometry, (CD19 expression ≥ 70% of AML blasts)
- Patients with R/R AML defined as:
- Primary refractory: absence of remission after two courses of induction chemotherapy,
- Secondary refractory: absence of remission after salvage treatment in relapsing patients,
You likely can't join if
- Patient unable to sign the informed consent,
- Patient with R/R AML that does not expresses CD19,
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease-free and without...
- Prior CD19 targeted therapy,
- Prior CAR therapy or other genetically modified T cell therapy,
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for...
See the full eligibility criteria
- Subject is ≥ 18 years of age at the time of signing the informed consent form,
- Patient with AML that expresses CD19 by Flow-cytometry, (CD19 expression ≥ 70% of AML blasts)
- Patients with R/R AML defined as:
- Primary refractory: absence of remission after two courses of induction chemotherapy,
- Secondary refractory: absence of remission after salvage treatment in relapsing patients,
- Post-transplant relapse in patients having had allo-HCT.
- Lack of accessible targeted therapy that has not been previously utilized.
- Eastern Cooperative Oncology Group (ECOG) performance status of \< 2,
- Estimated life expectancy of \> 2 months,
- Magnetic resonance imaging (MRI) of the brain showing no evidence of central nervous system (CNS) involvement,
- Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities, such as alopecia),
- Platelet count ≥ 30000/uL,
- Absolute lymphocyte count ≥ 200/uL,
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 40 mL/min,
- Serum ALT/AST ≤ 2.5 upper limit of normal (ULN),
- Total bilirubin ≤ 1.5 mg/dl, except in people with Gilbert's syndrome,
- Cardiac ejection fraction ≥ 45 %,
- No clinically significant electrocardiogram (ECG) findings,
- No clinically significant pleural effusion,
- Baseline oxygen saturation \> 92 % on room air,
- Female patients of childbearing potential must:
- have a negative pregnancy test (blood) at screening visit.
- either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective measures of contraception without interruption, from screening through 1 year following the CAR-T cell...
- Agree to abstain from breast feeding during the study participation and for 1 year after the CAR-T cell infusion.
- Male patients must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 1 year after the CAR-T cell infusion, even if he has...
- Patient unable to sign the informed consent,
- Patient with R/R AML that does not expresses CD19,
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease-free and without anticancer therapy for at least 3 years,
- Prior CD19 targeted therapy,
- Prior CAR therapy or other genetically modified T cell therapy,
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management,
- History of human immunodeficiency virus (HIV) or HTLV1,
- Infection or acute or chronic active hepatitis C infection,
- Infection or acute or chronic active hepatitis (Hep) B. people with history of Hep B or Hep C infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious...
- people with detectable cerebrospinal fluid malignant cells or known brain metastases or with a history of cerebrospinal fluid (CSF) malignant cells or brain metastases,
- History or presence of non-malignant CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement,
- Patient placed under guardianship or curatorship,
- Females either pregnant/breast-feeding or planning to become pregnant,
- Any contraindication due to hypersensitivity to the active substance or to any of the excipients,
- Contraindication to the lymphodepleting chemotherapy,
- Absence of medical insurance cover.
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.