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

NCT04012892 | Unknown Phase 1 DMC

• 1 other identifier: HEM-NHL001-CART
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed Non-Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

study group

EXPERIMENTAL

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

Interventions

CD19 CART COMBINATION_PRODUCT

CD19 CART

study group

Eligibility Criteria

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

You may qualify if:

• Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
• Age 18 to 65 years old, both male and female;
• Is expected to survive more than 12 weeks;
• Physical condition is good: 0-1 score ECOG score;
• No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
• 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.

You may not qualify if:

• 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;
• Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
• Pregnancy and lactation women;
• Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
• The Investigator believe the patients should not participate in this experiment.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Shenzhen University: collaborator
• Shenzhen University General Hospital: collaborator

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, 518000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lixing Wang, MD

CONTACT

86-0755-21839178; wanglixin1991@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 9, 2019
• Study Start: May 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: June 1, 2021
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

CN (1)