NCT06160362

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

November 29, 2023

Last Update Submit

December 6, 2023

Conditions

Non-hodgkin Lymphoma,B Cell

Keywords

non-Hodgkin's lymphomaCART

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • objective response rate

    28 days and 3 months after recieving intravenous CART cells

  • peripheral blood CART cell copy number

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

Study Arms (1)

double-target CART-19 and 20

EXPERIMENTAL

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 cellsDrug: CyclophosphamideDrug: Fludarabine

Interventions

CART-19 and 20 cellsBIOLOGICAL

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

double-target CART-19 and 20
CyclophosphamideDRUG

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

double-target CART-19 and 20
FludarabineDRUG

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

double-target CART-19 and 20

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 75 years old (including 18 and 75)
  • Diagnosed as R/R NHL
  • CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry
  • Having at least one measurable lesions
  • World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
  • Life expectancy no less than 3 months
  • enough main organ function
  • 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
  • Agreeing to sign the written informed consents

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Zhihua Yao, M.D. Ph.D

    Henan Cancer Hospital

    STUDY DIRECTOR

Central Study Contacts

Zhihua Yao, M.D. Ph.D

CONTACT

+8613592622292zlyyyaozhihua1260@zzu.edu.cn

Yanyan Liu, M.D. Ph.D

CONTACT

+8613838176375yyliu@zzu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

October 31, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations

CN(1)