Actively Recruiting
Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B-ALL
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-02-25
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of CD19 and CD22 targeted prime CAR-T cell therapy for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). This study addresses patients who have not responded to previous anti-CD19 CAR-T treatments or who have experienced relapse without CD19 expression. The goal is to improve outcomes for these patients using a new targeted CAR-T cell approach. Participants will receive a single intravenous infusion of CD19 and CD22 targeted prime CAR-T cells as the experimental treatment. This single-arm study involves no placebo or comparison group. The therapy targets both CD19 and CD22 proteins on leukemia cells to potentially overcome resistance seen with prior treatments. During the study, participants will be closely monitored for adverse events related to the treatment for up to two years. Researchers will assess the response rate to the CAR-T therapy over six months and track various measures such as CAR-T cell presence in bone marrow and blood, immune factors like IL-6 and TNF-alpha, and survival outcomes. Patients will have regular visits and evaluations to ensure safety and to collect data on the therapy's effects.
CONDITIONS
Brief Title
a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Diagnosed with relapsed or refractory B-ALL meeting one of these: failed standard chemotherapy, relapse after remission with high-risk or refractory disease, or relapse after stem cell transplant
- For Ph+ ALL patients: must have received standard induction chemotherapy and have not achieved remission after TKI treatment or have relapsed, excluding drug-resistant patients
- Evidence of CD19 or CD22 expression on leukemia cells
- All genders aged 2 to 75 years
- Expected survival time longer than 3 months
- Karnofsky Performance Status above 60
- No serious mental disorders
- Left ventricular ejection fraction 50% or higher
- Adequate liver function (ALT/AST ≤3 times upper limit, bilirubin ≤2 times upper limit)
- Adequate kidney function defined by creatinine clearance ≤2 times upper limit
- Adequate lung function with oxygen saturation ≥92%
- Able to provide blood or cell samples without contraindications
- Willing and able to follow study visit schedule and protocol requirements
You will not qualify if you...
- History of other malignancies
- Uncontrolled active infections
- Conditions requiring glucocorticoid treatment
- Active or chronic graft-versus-host disease (GVHD)
- Treatment with T-cell inhibitors
- Pregnant or breastfeeding women
- Any condition deemed unsuitable by investigators, including HIV, hepatitis C infection, or intravenous drug addiction that may affect study data analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive a single infusion of CD19 and CD22 targeted prime CAR-T cells intravenously to treat relapsed or refractory B-ALL.
1 baseline visit and multiple follow-up visits during treatment
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes including adverse events, response rate, and survival for up to 2 years after treatment.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
920th Hospital of Joint Logistics Support Force
Kunming, Yunnan, China
Actively Recruiting
Research Team
Z
Zhi Yang, PhD
S
Sanbin Wang, MD
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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