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

Non-hodgkin Lymphoma,B Cell Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160362
• Other study ID #: Th_C155
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Henan Cancer Hospital
• Contact: Zhihua Yao, M.D. Ph.D
• Phone: +8613592622292
• Email: zlyyyaozhihua1260[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma,B Cell

Intervention

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).
• Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2).

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety as assessed by the occurrence of study related adverse events	monitor the occurrence of study related adverse events	from the date of recieving intravenous CART cells up to one month
Secondary	objective response rate	the proportion of patients benefit from the therapy	28 days and 3 months after recieving intravenous CART cells
Secondary	peripheral blood CART cell copy number	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