Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma

NCT05239676 | Unknown Early Phase 1 DMC

• 1 other identifier: AUTO-CART-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma

Conditions

Lymphoma

Keywords

ASCT; CD19 CAR-T

Outcome Measures

Primary Outcomes (2)

• overall response rate

  the number of response patients/the number of total patients

  Up to 30 months

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  24 months after cell infusion

Secondary Outcomes (4)

• Overall response rate(ORR)

  Month 1,3,6,12,18and 24

• Progression-free survival (PFS)

  Month 6,12,18and 24

• Overall survival (OS)

  Month 6,12,18and 24

• Duration of response(DOR)

  Month 6,12,18and 24

Study Arms (1)

Treatment of Lymphoma

EXPERIMENTAL

Refractory and relapsed malignant lymphoma

Biological: Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells

Interventions

Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells BIOLOGICAL

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

Treatment of Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmed include: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphoma Subject.
• R/R B-NHL (conform one of the following conditions)
• The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy
• Primary resistance
• The subject relapsed after receiving autologous hematopoietic stem cell transplantation

You may not qualify if:

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Pregnant (or lactating) women;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Those who have used any gene therapy products before.
• The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
• Those who suffer from other uncontrolled diseases are not suitable to join the study;
• HIV infection;
• Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• He Huang, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, PhD

CONTACT

+8613605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

+8615957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: February 15, 2022
• Study Start: February 28, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CN (1)