Clinical trial NCT03598179: XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
Official title: A Single-center, Open Study Evaluating Efficacy and Safety of XLCART001（CD-19） Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Leukemia, B-cell
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate
timeFrame: 12 weeks
measure: Overall Survival
timeFrame: 6 months,1 year, 2 years
measure: Progression-free Survival
timeFrame: 12 weeks,6 months,1 year, 2 years
measure: Event-free Survival
timeFrame: 12 weeks,6 months,1 year, 2 years
Secondary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 28 days
measure: Number of CAR-T cells
timeFrame: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
measure: Duration of CAR-T cells
timeFrame: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
Other outcomes:
Locations:
city: Nanjin
country: China
facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
state: Jiangsu
Study officials:
References:
citation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.