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Application of antiCD19 CAR T lymphocytes for the treatment of adult patients with B-cell acute lymphoblastic leukemia with resistance, relapse or detectable measurable residual disease. Phase I/II clinical trial (MERMAID1)
EU CTIS ID: 2024-519808-27-00
What this study is testing
The aim of the study is to evaluate the safety and efficacy of anti-CD19 CAR T cells in the treatment of acute lymphoblastic leukemia Bcell with resistance, relapse or with positive measurable residual disease (MRD+) in adults.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Diagnosis of B-ALL on blast cells at the time of resistance, relapse, or measurable residual disease (MRD)
- 10. In men capable of having children, declaration of refraining from heterosexual sexual intercourse or using an appropriate method of contraception (as in point 4.3) by themselves and/or their partners (if capable of having children) after signing an informed consent for a period of 12 months from the start of therapy CAR-T.
- 2. Resistance, relapse, or presence of MRD defined as at least 0.01% of leukemic lymphoblasts among bone marrow cells.
- 3. Prior use of at least two cycles of chemotherapy
- 4. Age >18 years on screening date
- 5. Performance status assessed in the ECOG (Eastern Cooperative Oncology Group) scale of ≤ 2
You likely can't join if
- 1. Diagnosis of B-cell lymphoblastic lymphoma (presence of <20% leukemic blasts in blood or bone marrow at diagnosis)
- 10. Platelet count <50,000/μL unless, in the opinion of the investigator, the cytopenia is potentially reversible
- 11. Absolute lymphocyte count <100/μL
- 12. Other co-morbidities that have been assessed as likely to interfere with the conduct of the study, as assessed by the investigator
- 13. Pregnancy or breastfeeding
- 14. Women of childbearing potential or men who do not consent to the use of an effective method of contraception (as in section 4.3) while participating in the study
See the full eligibility criteria
Who can join
- 1. Diagnosis of B-ALL on blast cells at the time of resistance, relapse, or measurable residual disease (MRD)
- 10. In men capable of having children, declaration of refraining from heterosexual sexual intercourse or using an appropriate method of contraception (as in point 4.3) by themselves and/or their partners (if capable of having children) after signing an informed consent for a period of 12 months from the start of therapy CAR-T.
- 2. Resistance, relapse, or presence of MRD defined as at least 0.01% of leukemic lymphoblasts among bone marrow cells.
- 3. Prior use of at least two cycles of chemotherapy
- 4. Age >18 years on screening date
- 5. Performance status assessed in the ECOG (Eastern Cooperative Oncology Group) scale of ≤ 2
- 6. Satisfactory organ function during screening: A. ALT / AST activity <4 x Upper Limit of Normal (ULN) and total bilirubin <2 mg / dL (<4 mg / dL in patients with Gilbert's syndrome); B. Ejection fraction (EF)> 40% confirmed by ECHO, with no significant pericardial effusion within 6 weeks prior to screening; C. Respiratory capacity: arterial blood saturation> 92% without oxygen therapy, no significant pleural effusion; D. Creatinine clearance> 30 ml / min
- 7. Understanding and providing informed consent to participate in the study;
- 8. Negative pregnancy test (serum) in women of childbearing age.
- 9. In women capable of having children, a declaration to refrain from heterosexual sexual intercourse or to use an appropriate method of contraception (as in point 4.3) after signing the informed consent form for a period of 12 months after the use of CAR-T therapy. If hormonal contraception is used, the period of use must begin at least one month before the use of CAR-T therapy. If hormonal contraception is used, the period of its use must start at least one month before the use of CAR-T therapy.
What rules you out
- 1. Diagnosis of B-cell lymphoblastic lymphoma (presence of <20% leukemic blasts in blood or bone marrow at diagnosis)
- 10. Platelet count <50,000/μL unless, in the opinion of the investigator, the cytopenia is potentially reversible
- 11. Absolute lymphocyte count <100/μL
- 12. Other co-morbidities that have been assessed as likely to interfere with the conduct of the study, as assessed by the investigator
- 13. Pregnancy or breastfeeding
- 14. Women of childbearing potential or men who do not consent to the use of an effective method of contraception (as in section 4.3) while participating in the study
- 15. Inability to give informed consent to participate in a study
- 2. Isolated central nervous system (CNS) relapse
- 3. History of significant diseases of the central nervous system (CNS) or significant current CNS disorders (seizures, paralysis, aphasia, CNS ischemia / hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, psychosis and diseases associated with incoordination or movement disorders)
- 4. The need for systemic immunosuppressive therapy
- 5. Allogeneic hematopoietic cells (alloHCT) transplant surgery in less than 3 months prior to screening
- 6. Concurrent presence of another neoplasm and another neoplasm diagnosed up to 2 years prior to study enrollment
- 7. Active bacterial, viral or fungal infections, including SARS-CoV2
- 8. Positive serology results towards HIV (antigene and/or anti-HIV), HBV ( HbsAg and/ or anti-HbsAg) and HCV ( anti-HCV)
- 9. Absolute neutrophil count <500/μL unless, in the opinion of the investigator, the cytopenia is potentially reversible
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.