Actively Recruiting
Safety and Efficacy Study of Anti-CD19-CAR-T Cell Infusion in Relapsed/Refractory B-cell Tumor Patients
Led by Shanghai Tongji Hospital, Tongji University School of Medicine · Updated on 2024-04-19
12
Participants Needed
1
Research Sites
730 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating anti-CD19-CAR-T cell therapy in patients with relapsed or refractory B-cell tumors, including acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). This early phase 1, open-label trial uses a traditional 3+3 dose escalation design to study the safety and dose-limiting toxicity of this treatment after a pre-treatment called Qinglin. The study focuses on patients whose cancer has returned or not responded to standard treatments and who meet specific disease and health criteria. Participants will undergo a screening period, peripheral blood mononuclear cell collection, and lymphocyte depletion before receiving a single intravenous infusion of anti-CD19-CAR-T cells. The infusion doses will escalate through three planned levels: 1x10^5, 3x10^5, and 1x10^6 CAR-positive cells per kilogram. The infusion is administered via pump at 2 to 5 mL/min over less than 30 minutes. Supportive care such as antibiotics and blood transfusions may be given as needed. Baseline and efficacy assessments are scheduled monthly for ALL patients and at weeks 4, 12, 24, 36, and 48 for NHL patients, continuing until disease progression or other defined endpoints. Throughout the study, participants will be closely monitored with laboratory tests, electrocardiograms, vital signs, and physical exams to evaluate safety and therapy effects. Blood samples will be analyzed for cellular pharmacokinetics and immune markers like ferritin and cytokines. The primary outcome is the occurrence of dose-limiting toxicity within 28 days post-infusion. Participants may remain in the study until disease progression, relapse, treatment change, intolerable toxicity, death, or withdrawal. The total study duration varies based on individual patient status and response.
CONDITIONS
Brief Title
Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent.
- Age between 18 and 70 years.
- Patients with relapsed or refractory B-cell acute lymphoblastic leukemia or non-Hodgkin lymphoma after standard treatments.
- Bone marrow tumor cells ≥5% in ALL patients.
- Specific NHL subtypes including DLBCL-NOS, PMBCL, transformed follicular lymphoma, mantle cell lymphoma, high-grade B-cell lymphoma, and CLL/SLL.
- ECOG performance status ≤2.
- Estimated life expectancy of at least 12 weeks.
- Adequate venous access and no contraindications to blood cell separation.
- Laboratory tests meeting defined safety thresholds.
- Left ventricular ejection fraction ≥45% and no significant heart or oxygen issues.
- Negative pregnancy test for women of childbearing potential.
You will not qualify if you...
- Central nervous system abnormalities including CNS-3 or CNS-2 with neurological changes.
- Central nervous system lymphoma or active CNS diseases.
- Other concurrent or previous malignancies except certain controlled cases.
- Significant cardiac diseases or uncontrolled infections.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis.
- Presence of certain catheters or drainage tubes excluding specific central venous devices.
- Prior CD19-targeted therapy or recent use of certain immunosuppressive, chemotherapeutic, or targeted drugs.
- Active graft-versus-host disease requiring systemic steroids above physiological doses.
- Recent history of autoimmune diseases with organ damage.
- Recent severe cardiac events or genetic syndromes causing bone marrow failure.
- Recent deep vein thrombosis or pulmonary embolism requiring anticoagulation.
- Pregnancy, lactation, or unwillingness to use contraception.
- Medical conditions interfering with study assessments or inability to comply with study visits.
- Previous use of any CAR-T or genetically modified T cell therapies.
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 - Duration as per protocol before treatment infusion
Participants undergo peripheral blood mononuclear cell (PBMC) collection and lymphocyte depletion pre-treatment.
1 to 2 visits depending on pre-treatment requirements
Duration - Single infusion with observation up to 28 days for dose-limiting toxicity
Participants receive a single infusion of anti-CD19-CAR-T cells with possible prophylactic medication and supportive care as needed.
1 infusion visit plus multiple safety monitoring visits during 28 days post-infusion
Duration - Up to 48 weeks or until disease progression or withdrawal
Efficacy and safety assessments are conducted monthly for acute lymphoblastic leukemia (ALL) participants and at weeks 4, 12, 24, 36, and 48 post-treatment for non-Hodgkin lymphoma (NHL) participants until disease progression or other study endpoints.
Monthly visits for ALL participants; visits at weeks 4, 12, 24, 36, and 48 for NHL participants
Trial Site Locations
Total: 1 location
1
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China, 200333
Actively Recruiting
Research Team
A
Aibin Liang
P
Ping LI
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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