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Therapeutic strategy driven by residual disease for CARCIK-CD19 in patients with relapsed/refractory B cell precursor Acute Lymphoblastic Leukemia
EU CTIS ID: 2024-519394-19-00
What this study is testing
To confirm the high overall response rate at day 28 after the first CARCIK-CD19 infusion and to improve the duration of response of patients treated with CARCIK -CD19 cells.
- Therapeutic exploratory (Phase II)
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
- Children (1-17) and adults (18-75 years old);
- Absence of severe renal disease (creatinine > x 3 normal for age);
- Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500);
- Patient/guardian able to give informed consent.
- Relapsed or refractory adult and pediatric BCP-ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR;
- Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
You likely can't join if
- GVHD Grades II-IV for patients who had previously been transplanted;
- Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia;
- Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible
- Any cell therapy in the last 30 days;
- Patient with concomitant life-threatening infectious disease;
- Lansky/Karnofsky score <60;
See the full eligibility criteria
- Children (1-17) and adults (18-75 years old);
- Absence of severe renal disease (creatinine > x 3 normal for age);
- Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500);
- Patient/guardian able to give informed consent.
- Relapsed or refractory adult and pediatric BCP-ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR;
- Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening, or if <5%, with at least 1% of molecular disease at PCR;
- No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
- No longer taking immunosuppressive agents for at least 30 days prior to infusion;
- No evidence of concomitant life-threatening infectious disease;
- Life expectancy > 60 days;
- Lansky/Karnofsky scores > 60;
- GVHD Grades II-IV for patients who had previously been transplanted;
- Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia;
- Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible
- Any cell therapy in the last 30 days;
- Patient with concomitant life-threatening infectious disease;
- Lansky/Karnofsky score <60;
- Patients with hepatic or renal disease as specific above;
- Pregnant or breast feeding females;
- Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
- Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met;
- HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG);
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, 0-17 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.