Actively Recruiting
CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma
Led by Affiliated Hospital to Academy of Military Medical Sciences · Updated on 2025-02-19
20
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Diagnosed relapsed or refractory CD19/CD22 positive B cell Leukemia or Lymphoma confirmed by immunohistochemistry or flow cytometry
- B-cell tumors include B-cell acute lymphoblastic leukemia, indolent B-cell lymphoma, or aggressive B-cell lymphoma
- Refractory or recurrent disease as defined by relapse within 12 months after first remission, failure to achieve remission after chemotherapy, or recurrence after stem cell transplantation
- Prior treatment with rituximab or another anti-CD20 monoclonal antibody unless tumor is CD20-negative
- All genders, aged 14 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Life expectancy of at least 3 months
- Hemoglobin level at least 70 g/L
- Adequate liver, kidney, and cardiopulmonary function including creatinine ≤1.5× upper limit of normal, left ventricular ejection fraction ≥50%, oxygen saturation over 90%, total bilirubin ≤1.5× upper limit of normal, ALT and AST ≤2.5× upper limit of normal
- Agreement to use contraception from consent until 1 year after CAR-T cell infusion
You will not qualify if you...
- Severe heart failure with left ventricular ejection fraction below 50%
- History of severe lung function impairment
- Presence of other advanced malignant tumors
- Severe infection that cannot be effectively controlled
- Severe autoimmune disease or congenital immune deficiency
- Active hepatitis B or C infection with detectable viral DNA or RNA
- HIV infection, AIDS, or syphilis infection
- History of severe allergy to biological products including antibiotics
- Acute graft-versus-host disease within one month after immunosuppressant withdrawal in allogeneic stem cell transplant patients
- Serious physical or mental illnesses or laboratory abnormalities increasing risk or interfering with study participation, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
H
Hongmei Ning, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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