Clinical trial NCT04923789: A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma
Official title: A Clinical Study to Evaluate the Efficacy and Safety of Autologous Hematopoietic Stem Cell Transplantation(ASCT) Bridging Chimeric Antigen Receptor T(CART) Cell Therapy in the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Relapsed Non Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
First posted: 2021-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The total number of patients was 60.

Brief summary: This is a single center, prospective cohort study to to evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation(ASCT) bridging chimeric antigen receptor T (CART) cell therapy in the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma.

Detailed description: High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation(ASCT) is still the standard salvage treatment for relapsed/refractory B-cell non-Hodgkin's lymphoma (R/R B-NHL). However, its overall survival (OS) and event-free survival (EFS) of 3 years and above are less than 50%. Chimeric antigen receptor T (CART) cell therapy has shown great efficacy in treating B-NHL in recent years. Preclinical studies have indicated that the infusion of hematopoietic stem cells could promote the amplification and function of adoptive metastatic anti-tumor CD8+T cells, providing a certain theoretical basis for ASCT combined with CART cell therapy. In order to evaluate the efficacy and safety of ASCT bridging CART cell therapy in treating R/R B-NHL, we conduct this single center, prospective cohort study.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed B-NHL with extrinsic involvement.
2. Age ≥ 18 years and ≤ 65 years.
3. Measurable disease of at least 15mm(node)/10mm（extranodal）
4. Meet any of the following conditions :1. After 4 courses of standard first-line treatment or 2 courses of treatment with more than two lines, the lesions decreased by less than 50%;2 B-NHL with disease progression after first-line or induction treatment;3. Relapsed B-NHL within 12 months after ASCT;4. After standard chemotherapy or hematopoietic stem cell transplantation, the size of any new lesions or the previously involved site which had achieved complete remission increased by 50% or more.
5. Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2\*10\^6/kg.
6. Estimated survival time ≥3 months

Exclusion Criteria:

1. Having received allogeneic hematopoietic stem cell transplantation previously;
2. HIV-positive;
3. Active hepatitis B or C infection;
4. Previous history of other malignant tumors. Excluded: Patients who had cured basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; Patients with disease-free survival ≥5 years who had been cured by surgery only without further treatment for the other tumors listed above can be included in the study.
5. Patients with cardiac insufficiency:ejection fraction (EF) \< 30%, NYHA standard, grade II or above
6. Patients with liver and renal insufficiency: Serum Direct Bilirubin (SB) ≥2mg/ dL (34.2μmol/L), Aspartate Aminotransferase(AST) \> 2.5 times the up, Serum Creatinine (SCR) \> 2.5mg/ dL (221μmol/L)
7. Female patients who are pregnant, preparing to become pregnant or lactating.
8. The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.

Primary outcomes:
measure: Progression-free Survival(PFS)
timeFrame: up to 12 months
measure: Overall Survival(OS)
timeFrame: up to 12 months
Secondary outcomes:
measure: Duration of Response(DOR)
timeFrame: up to 12 months
measure: Adverse Events(AE)
timeFrame: Measured from start of treatment until 28 days after last treatment.
measure: Overall Response Rate(ORR)
timeFrame: up to 12 months
measure: Cumulative Recurrence Rate
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu
role: STUDY_CHAIR
References: