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Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma

Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for Chemotherapy-resistant or Refractory CD19+B Cell Lymphoma:a Double-arm, Single Center, Open-label Clinical Trial

NCT02992834•jiangjingting

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma.

Detailed Description

This is a single-centre, randomised, open label Phase I clinical trial of CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma. Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Enrollment for enough male or female patients with CD19+ hematological malignancies, without regimens for cure (autologous or allogeneic stem cell transplantation), and having a poor prognosis (several months to 2 years) under current optional regimens
•1. Age ranges from 18 to 70 years old
•2. Expected survival time longer than 12 weeks
•3. Performance status score 0-2
•4. Pathologically confirmed CD19+ lymphoma (CD19+ follicular lymphoma, Mantle cell lymphoma, diffuse large B cell lymphoma) and meets at least one of follows:
•1. having received at least 2-4 cycles of combined chemotherapy (excluding monoclonal antibody monotherapy, such as rituximab) but do not reach a complete response; recurrent disease; not applicable for conventional stem cell transplantation; being partial responsible or stable but not complete responsible after the latest therapy
•2. recurrence develops after stem cell transplantation
•3. diagnosis confirmed but refusing to receive conventional therapy
•5. Creatinine\<2.5 mg/dl；
•6. alanine aminotransferase/aspartate aminotransferase lower than 3 folds of normal range
+4 more criteria

Exclusion Criteria

•1. Central nerve system invasion with symptoms
•2. Other concurrent uncontrolled malignancies
•3. Hepatitis B infection or active period of hepatitis C, HIV infection
•4. Other uncontrolled diseases hampering the intervention in the study
•5. Coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious cardiovascular or cerebrovascular diseases.
•6. Grade 2-3 or uncontrolled hypertension
•7. History of uncontrolled mental disease
•8. Not suitable for participation judged by researchers
•9. Immunosuppressive agents administered due to organ transplantation, not including recent or current inhaled corticosteroid
•10. Medical history of mental diseases or abnormities of lab tests might increase the risks of participation in study or drug administration, or interfering the results
+6 more criteria

Locations (1)

First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Key Dates

Start Date

December 1, 2016

Primary Completion Date

August 1, 2020

Completion Date

January 1, 2022

Last Updated

December 14, 2016

Enrollment

ESTIMATED participants

Conditions

Lymphoma, B Cell

Interventions

IL-2 pre-treated CD19 cells

BIOLOGICAL

IL-7/IL-15 pre-treated CD19 cells

BIOLOGICAL

Contacts

Jingting Jiang, Professor

CONTACT

jjtnew@163.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: December 14, 2016Data 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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