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A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma | Clinical Trials | Clareo Health

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

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

NCT04923789•The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

September 1, 2020

Primary Completion Date

March 1, 2022

Completion Date

March 1, 2023

Last Updated

June 11, 2021

Enrollment

ESTIMATED participants

Conditions

Relapsed Non Hodgkin LymphomaRefractory Non-Hodgkin Lymphoma

Contacts

Caixia Li, M.D.

CONTACT

+86 512 67781856 licaixia@suda.edu.cn

Jia Chen, M.D.

CONTACT

+86 512 67781856 chenjiasuzhou@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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