Loading clinical trials...

UNKNOWNEARLY_PHASE1

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research

NCT05715606•Anhui Provincial Hospital

Summary

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma

Detailed Description

This is a single arm, open-label study. This study is indicated for relapsed or refractory CD19+ Diffuse Large B-Cell Lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 1. Main research objectives: To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r DLBCL. 2. Secondary research objectives: （1）To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion. （2）To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient or his/her guardian voluntarily signed the informed consent;
•2. Adult Patients with relapsed and refractory diffuse large B-cell lymphoma (Primary mediastinal large B-cell lymphoma and transformed follicular lymphoma are included)
•Definition of refractory:
•1. No response to the last treatment, including:
•The best response to the last treatment was PD, or ; The best response to the last treatment was SD and the duration was not more than 6 months after the last dose.
•2. Not suitable for autologous hematopoietic stem cell transplantation (ASCT), or ASCT refractory, including:
•Disease progression or recurrence within 12 months or less (recurrence must be confirmed by biopsy) after ASCT treatment, or; Patients accept remedial treatment after ASCT must have no response or relapse after the last treatment.
•3. Patients who had previously received ≥2 lines therapy including at least:
•1. A chemotherapy regimen containing anthracyclines；
•2. For patients with transformed DLBCL from follicular lymphoma, they must have previously received chemotherapy for follicular lymphoma and have refractory disease after transformation to DLBCL.
+17 more criteria

Exclusion Criteria

•1. Patients with present or history of central nervous system diseases such as seizures disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
•2. Patients with history of allogeneic hematopoietic stem cell transplantation
•3. Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion
•4. Patients who participated in other clinical trials within 30 days prior to enrollment
•5. Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \> 1000 copies/ml) or hepatitis C (HCV RNA positive)
•6. Patients with HIV antibody positive or treponema pallidum antibody positive
•7. Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19 infusion)
•8. Patients with unstable angina pectoris and/or myocardial infarction within 6 months prior to enrollment
•9. Patients with history of other malignancies, but the following conditions can be enrollment:
•1. Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent);
+5 more criteria

Locations (1)

Anhui Provincial Hospital

Hefei, Anhui, China

Key Dates

Start Date

February 10, 2023

Primary Completion Date

February 1, 2025

Completion Date

May 15, 2025

Last Updated

July 5, 2023

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Metabolically Armed CD19 CAR-T cells

DRUG

Contacts

Xingbing Wang, PhD

CONTACT

86-13856007984 wangxingbing@ustc.edu.cn

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE3

A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT01804686

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma+5 more

View study

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: July 5, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

Long-term Follow up Local Registry Study of Kymriah in South Korea

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms