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RecruitingNCT06160362Updated Dec 7, 2023

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

An interventional study of CART-19 and 20 cells and Cyclophosphamide in Non-hodgkin Lymphoma,B Cell, sponsored by Henan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by Henan Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-hodgkin Lymphoma,B Cell

Keywords

  • non-Hodgkin's lymphoma
  • CART
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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 · Drug: Cyclophosphamide · Drug: Fludarabine

Interventions

  • BiologicalCART-19 and 20 cells

    Double-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy.

  • DrugCyclophosphamide

    patients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2).

  • DrugFludarabine

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

06

What researchers measure

Primary outcomes

  1. safety as assessed by the occurrence of study related adverse events

    monitor the occurrence of study related adverse events

    Time frame: from the date of recieving intravenous CART cells up to one month

Secondary outcomes

  1. objective response rate

    the proportion of patients benefit from the therapy

    Time frame: 28 days and 3 months after recieving intravenous CART cells

  2. 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

    Time frame: from the date of recieving intravenous CART cells up to one month

07

Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
    Zhengzhou, Henan, China
    • Zhihua Yao, M.D. Ph.D · Contact · zlyyyaozhihua1260@zzu.edu.cn · +8613592622292
    • Yanyan Liu, M.D. Ph.D · Contact · yyliu@zzu.edu.cn · +8613818176375
    • Zhihua Yao, M.D. Ph.D · Principal investigator
    • Yanyan Liu, M.D. Ph.D · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06160362
Lead sponsor
Henan Cancer Hospital
Responsible party
Zhihua Yao, PhD (Director, Henan Cancer Hospital) — Principal investigator
First posted
Dec 7, 2023
Start date
Oct 31, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Dec 7, 2023

Study contacts

Zhihua Yao, M.D. Ph.D
Contact
zlyyyaozhihua1260@zzu.edu.cn
+8613592622292
Yanyan Liu, M.D. Ph.D
Contact
yyliu@zzu.edu.cn
+8613838176375
Zhihua Yao, M.D. Ph.D
study director · Henan Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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