The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)

December 6, 2023 updated by: Zhihua Yao, PhD, Henan Cancer Hospital

The Safety and Efficacy of Double-target CART-19 and 20 Cells in Relapse and Refractory Patients With CD19+/CD20+ Non-Hodgkin's Lymphoma (NHL)

This is a study for patients who have been previously treated for NHL. The purpose of this study is to determine the safety and feasibility of double-target CART-19 and 20 cells to the patients with relapsed and refractory CD19+/CD20+ NHL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yanyan Liu, M.D. Ph.D
  • Phone Number: +8613838176375
  • Email: yyliu@zzu.edu.cn

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
        • Contact:
        • Principal Investigator:
          • Yanyan Liu, M.D. Ph.D
        • Contact:
        • Principal Investigator:
          • Zhihua Yao, M.D. Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 to 75 years old (including 18 and 75)
  2. Diagnosed as R/R NHL
  3. CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry
  4. Having at least one measurable lesions
  5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
  6. Life expectancy no less than 3 months
  7. enough main organ function
  8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and 12 months after this study
  9. Agreeing to sign the written informed consents

Exclusion Criteria:

  1. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 12 months
  2. Active GVHD
  3. History of severe pulmonary dysfunction
  4. Active malignant tumor need be treated at the same time
  5. Uncontrolled active acute/chronic infection
  6. Severe autoimmune diseases or congenital immunodeficiency
  7. Untreated active hepatitis
  8. HIV-positive, AIDS patients and syphilis infection
  9. History of severe allergies to biological products
  10. Patients with a history of mental illness
  11. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
  12. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: double-target CART-19 and 20
Patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of double-target CART-19 and 20 cells. The double-target CART-19 and 20 cells are to be administered on day0.
Biological: CART-19 and 20 cells
Double-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy.
Drug: Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2).
Drug: Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety as assessed by the occurrence of study related adverse events
Time Frame: from the date of recieving intravenous CART cells up to one month
monitor the occurrence of study related adverse events
from the date of recieving intravenous CART cells up to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: 28 days and 3 months after recieving intravenous CART cells
the proportion of patients benefit from the therapy
28 days and 3 months after recieving intravenous CART cells
peripheral blood CART cell copy number
Time Frame: from the date of recieving intravenous CART cells up to one month
The highest concentration of CART cells in peripheral blood, the time to reach the highest concentration, and the area under the curve at 28 days after recieving intravenous CART cells
from the date of recieving intravenous CART cells up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Study Director: Zhihua Yao, M.D. Ph.D, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Estimated)

December 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Th_C155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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