A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma

Refractory Non-Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923789
• Other study ID #: 2020173
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: August 2020
• Source: The First Affiliated Hospital of Soochow University
• Contact: Caixia Li, M.D.
• Phone: +86 512 67781856
• Email: licaixia[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Refractory Non-Hodgkin Lymphoma
• Relapsed Non Hodgkin Lymphoma

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival(PFS)	The last follow-up of a surviving patient after ASCT to the date of relapse, disease progression, death, dependent upon which occurred first over a follow-up period of 18 months.	up to 12 months
Primary	Overall Survival(OS)	The interval from the time of ASCT to death from any cause or to the last follow-up moment.	up to 12 months
Secondary	Duration of Response(DOR)	DOR will be assessed from ASCT to progression,death or last follow-up.	up to 12 months
Secondary	Adverse Events(AE)	Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated	Measured from start of treatment until 28 days after last treatment.
Secondary	Overall Response Rate(ORR)	Number of patients who achieved response after the treatment.	up to 12 months
Secondary	Cumulative Recurrence Rate	Cumulative number of patients who recurred after the treatment.	up to 12 months