Leukemia, B-cell, Lymphoma, B-Cell
Conditions
Brief summary
The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects
Interventions
BIOLOGICALchimeric antigen receptor T cells
Dose CAR+ cells/kg B-cell lymphoma 4×10\^6 Acute lymphocytic leukemia 2×10\^6 Chronic lymphocytic leukemia 10×10\^6
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years, male and female, * Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry * No effective treatment * Patients must have a measurable or evaluable disease at the time of enrollment. * Adequate organ system function including: * ALT/AST \< 3 upper limit of normal; Total Bilirubin \< 2.5 upper limit of normal * Creatinine \< 2 upper limit of normal * Oxygen saturation ≥ 95% * Left ventricular ejection fraction ≥ 40% * Number of neutrophil ≥ 0.75×10\^9/L, number of platelet ≥ 50×10\^9/L * At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments) * No contraindications of peripheral blood apheresis * Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures * ECOG score 0-2, expected survival ≥ 12 weeks
Exclusion criteria
* Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures * Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons * Subjects with any autoimmune disease or any immune deficiency disease * Have a history of allergy to antibodies or cellular products * Participated in any other clinical trial within four weeks * Used of systemic steroids within four weeks (using inhaled steroids or ≤ 20mg/d prednison are exceptions) * Have mental diseases * Have history of drug addiction * The investigators believe that any increase in the risk of the subject or interference with the results of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 12 weeks | Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12. |
| Overall Survival | 6 months,1 year, 2 years | from the time of enrollment to death from any cause or the date of the last follow-up visit |
| Progression-free Survival | 12 weeks,6 months,1 year, 2 years | the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit |
| Event-free Survival | 12 weeks,6 months,1 year, 2 years | the time from enrollment to any events, or the date of the last follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of CAR-T cells | Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years | The number of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction |
| Duration of CAR-T cells | Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years | The duration of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction |
| Dose-limiting toxicity (DLT) | 28 days | Non-haematological dose-limiting toxicities was any toxicity of grade 3 or higher occurring within 28 days of XLCART001 infusion judged possibly related to the treatment regimen.The following toxicities were not considered dose limiting toxicities: tumor lysis syndrome, abnormal electrolytes responding to supplementation, hypoalbuminemia, liver dysfunction resolving to ≤grade 2 within 14 days, transient (\<72 hours) grade 4 hepatic enzyme abnormality, and grade 3 or 4 fever or neutropenic fever. |
Countries
China
Outcome results
None listed