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New treatment option for ALL
Official title A Multicenter Study of CAR-T Cells in Primary Ph+All
ClinicalTrials.gov ID: NCT07252336
What this study is testing
What is CD19 CAR-T cells?
CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for all.
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
- A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years old, gender not restricted;
- people diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
- Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
- people positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
- Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
You likely can't join if
- people meeting any of the following exclusion criteria are ineligible for enrollment in this study:
- people with a history of epilepsy or other central nervous system diseases;
- people with a prior history of QT interval prolongation or severe cardiac diseases;
- Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- people with untreated active infections;
- people with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral...
See the full eligibility criteria
- Age ≥ 18 years old, gender not restricted;
- people diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
- Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
- people positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
- Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
- Serum total bilirubin ≤ 51 μmol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol/L;
- Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;
- people with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation;
- Estimated survival time ≥ 3 months;
- ECOG performance status score 0-2;
- Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;
- people voluntarily participate in this study and sign the informed consent form.
- people meeting any of the following exclusion criteria are ineligible for enrollment in this study:
- people with a history of epilepsy or other central nervous system diseases;
- people with a prior history of QT interval prolongation or severe cardiac diseases;
- Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- people with untreated active infections;
- people with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; people with...
- Human immunodeficiency virus (HIV) antibody positive;
- Syphilis antibody positive;
- people who have previously received any gene therapy products;
- people with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;
- Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
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 Hangzhou, Zhejiang, China. 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.