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New treatment option for Relapsed or Refractory B Cell Leukemia and Lymphoma
Official title CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma
ClinicalTrials.gov ID: NCT06834529
What this study is testing
What is CAR2219-T cells?
CAR2219-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory b cell leukemia and lymphoma.
Also referred to as Fludarabine, Cyclophosphamide.
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
- This is a single arm study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma.
- 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 14 to 75
You may be able to join if
- Signed written informed consent;
- Relapsed/refractory CD19/CD22 positive B cell Leukemia or Lymphoma must be assured and meet one of the following conditions: (1) Confirmation for...
- All genders, ages: 14 to 75 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- Life expectancy ≥3 months;
You likely can't join if
- Severe heart failure with left ventricular ejection fraction \<50%;
- A history of severe lung function impairment;
- Combined with other advanced malignant tumors;
- Complicated with severe infection that could not be effectively controlled;
- Severe autoimmune disease or congenital immune deficiency;
- Active hepatitis (hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] test results above the lower limit of detection);
See the full eligibility criteria
- Signed written informed consent;
- Relapsed/refractory CD19/CD22 positive B cell Leukemia or Lymphoma must be assured and meet one of the following conditions: (1) Confirmation for either CD19 or CD22 positivity using immunohistochemistry or flow...
- All genders, ages: 14 to 75 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- Life expectancy ≥3 months;
- HGB≥70g/L
- Liver,kidney function and cardiopulmonary function meet the following requirements: (1) creatinine ≤1.5×ULN; (2) left ventricular ejection fraction≥50%; (3) Oxygen saturation \>90%; (4) Total bilirubin ≤1.5×ULN, ALT and...
- Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion."
- Severe heart failure with left ventricular ejection fraction \<50%;
- A history of severe lung function impairment;
- Combined with other advanced malignant tumors;
- Complicated with severe infection that could not be effectively controlled;
- Severe autoimmune disease or congenital immune deficiency;
- Active hepatitis (hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] test results above the lower limit of detection);
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- History of severe allergy to biological products (including antibiotics);
- Allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients with acute graft-versus-host reaction (GVHD) one month after immunosuppressant withdrawal;
- Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 14 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.