Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma

This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma

Study Overview

• Status: Unknown
• Conditions: Refractory Non-Hodgkin Lymphoma; Relapsed Non-Hodgkin Lymphoma
• Intervention / Treatment: Combination product: CD19 CART

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lixing Wang, MD; Phone Number: 86-0755-21839178; Email: wanglixin1991@sohu.com

Study Locations

• China
  • Shenzhen, China, 518000
    • Recruiting
    • Shenzhen university General Hospital
    • Principal Investigator: Lixing Wang, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
2. Age 18 to 65 years old, both male and female;
3. Is expected to survive more than 12 weeks;
4. Physical condition is good: 0-1 score ECOG score;
5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
3. Pregnancy and lactation women;
4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
5. The Investigator believe the patients should not participate in this experiment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: study group; After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours	Combination product: CD19 CART; CD19 CART

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery rate of patients being treated with CD19CAR-T	the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T	6 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Shenzhen University General Hospital; Shenzhen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): April 30, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 7, 2019
• First Posted (ACTUAL): July 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 7, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: HEM-NHL001-CART

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No