Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
NCT ID: NCT05239676
Last Updated: 2022-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
50 participants
INTERVENTIONAL
2022-02-28
2024-12-01
Brief Summary
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Detailed Description
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CD19 CAR-T therapy as a consolidation therapy after high-dose melphalan and autologous hematopoietic stem cell transplantation has been used in a refractory MM patient at the University of Pennsylvania, and good research progress has been made. Craig S et al. studied the safety and effectiveness of CD19 CAR-T cell therapy after high-dose chemotherapy and autologous stem cell transplantation HDT-ASCT. The object of the study was relapsed and refractory non-Hodgkin's lymphoma, with 2-year progression-free survival ( PFS) is 30%.
Therefore, autologous hematopoietic stem cell transplantation combined with CAR-T cell therapy is expected to improve the complete remission rate and long-term survival rate. In summary, the center intends to apply for a clinical trial of autologous hematopoietic stem cell transplantation combined with CAR-T cells for the treatment of refractory and relapsed non-Hodgkin's lymphoma.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment of Lymphoma
Refractory and relapsed malignant lymphoma
Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
The patient receives ECHOP chemotherapy or other chemotherapy regimens； G-CSF in the low cell stage mobilizes hematopoietic stem cells and freezes them for later use after collection； Autologous hematopoietic stem cells and prepared CD19 CAR-T cells are reinfused into the patient
Interventions
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Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
The patient receives ECHOP chemotherapy or other chemotherapy regimens； G-CSF in the low cell stage mobilizes hematopoietic stem cells and freezes them for later use after collection； Autologous hematopoietic stem cells and prepared CD19 CAR-T cells are reinfused into the patient
Eligibility Criteria
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Inclusion Criteria
3.R/R B-NHL (conform one of the following conditions)
1. The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy
2. Primary resistance
3. The subject relapsed after receiving autologous hematopoietic stem cell transplantation
Exclusion Criteria
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Those who have used any gene therapy products before.
7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
8. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
9. Those who suffer from other uncontrolled diseases are not suitable to join the study;
10. HIV infection;
11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
18 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Principal Investigators
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He Huang, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
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The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AUTO-CART-001
Identifier Type: -
Identifier Source: org_study_id
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