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An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma | Clinical Trials | Clareo Health

UNKNOWNEARLY_PHASE1

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells Injection (Anti CD30 CAR T Cells) in Patients With CD30+ Relapsed/Refractory Lymphoma

NCT05208853•Zhejiang University

View on ClinicalTrials.gov

Summary

This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.

Detailed Description

This study is a single-center, open-label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma. This study intends to include CD30-positive patients with relapsed/refractory CD30+ lymphoma, and subjects will receive a single injection of anti CD30 CAR-T cells after screening, Peripheral Blood Mononuclear Cell (PBMC) collection, and lymphodepletion chemotherapy pretreatment. Response assessments for lymphoma subjects will base on 2018 Lugano Classification.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet all of the following criteria to be included in the group:
•1. Understand and sign the informed consent form, and voluntarily participate in clinical study;
•2. 18-70 years old, no gender limit;
•3. Patients with CD30+ lymphoma have received at least 2-line systemic treatment in the past and who have relapsed or are refractory, including but not limited to:
•1. Hodgkins lymphoma;
•2. Mature T-cell lymphoma, including but not limited to non-specific peripheral T cell lymphoma, angioimmunoblastic T-cell lymphoma, NK/T-cell lymphoma, anaplastic large-cell lymphoma;
•3. Diffuse large B-cell lymphoma, including but not limited to mediastinal B-cell lymphoma, gray zone lymphoma;
•4. Other lymphocytic proliferative tumors;
•4. Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1;
•5. Patients with sufficient venous access (for apheresis), and no other contraindications for blood cell separation;
+11 more criteria

Exclusion Criteria

•Patients cannot participate in this study if they meet any of the following conditions:
•1. Patients have a history of allergies to any component in cell therapy products.
•2. Patients received any CAR-T cell product or other genetically modified T cell therapy in the past.
•3. Patients received autologous or allogeneic hematopoietic stem cell transplantation within 3 months.
•4. Patients suffering from other malignant tumors in the past or present (except for skin basal cell carcinoma, breast/cervix carcinoma in situ and other malignant tumors that have not been treated and effectively controlled in the past five years).
•5. Patients who have received continuous systemic steroids (prednisone\> 5 mg/day or equivalent doses of other hormones) or other immunosuppressive agents within 14 days before apheresis, except those who have recently or currently used inhaled steroids.
•6. Patients with Hepatitis B (positive hepatitis B virus surface antigen and/or positive hepatitis B core antibody and hepatitis B DNA \> 10\^3 copies/mL) and Hepatitis C (positive hepatitis C antibody test).
•7. Patients with syphilis, human immunodeficiency virus (HIV) infection (HIV positive).
•8. Patients with hyponatremia and/or hypokalemia, blood sodium \< 125 mmol/L and/or blood potassium \< 3.5 mmol/L (Except that blood sodium and/or potassium were restored above this level by sodium and/or potassium supplementation before participating in this study).
•9. Patients was known or existing primary or metastatic central nervous system lymphoma, or with any other central nervous system disease (such as seizures, cerebral ischemia/hemorrhage, dementia, etc.).
+14 more criteria

Locations (1)

The First Affiliated Hospital, College of medicine, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

February 10, 2022

Primary Completion Date

February 10, 2022

Completion Date

February 10, 2022

Last Updated

January 26, 2022

Enrollment

ESTIMATED participants

Conditions

Hodgkin LymphomaNK/T Cell LymphomaPeripheral T Cell Lymphoma, UnspecifiedAngioimmunoblastic T-cell LymphomaAnaplastic Large Cell LymphomaDiffuse Large B Cell LymphomaMediastinal B-Cell Diffuse Large Cell LymphomaGray Zone Lymphoma

Interventions

Anti CD30 CAR-T Cell Injection

BIOLOGICAL

Contacts

Huang He, PhD

CONTACT

86-13605714822 hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012 huyongxian2000@aliyun.com

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RECRUITINGPHASE1

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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: January 26, 2022Data 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

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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