Non-hodgkin Lymphoma,B CellNCT06160362
The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)
A study testing CART-19 and 20 cells, Cyclophosphamide and Fludarabine in people with Non-hodgkin Lymphoma,B Cell, run by Henan Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-hodgkin Lymphoma,B Cell
- What is being tested?
- CART-19 and 20 cells, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan
Zhihua Yao, M.D. Ph.D, +8613592622292, zlyyyaozhihua1260@zzu.edu.cn
Yanyan Liu, M.D. Ph.D, +8613818176375, yyliu@zzu.edu.cn
About this study
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)
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.
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Being tested
- CART-19 and 20 cells, Cyclophosphamide, Fludarabine
- Keywords
- non-Hodgkin's lymphoma, CART
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-19 and 20 cellsBiological
Double-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy.
CyclophosphamideDrug
patients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2).
FludarabineDrug
Fludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: CART-19 and 20 cells; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety as assessed by the occurrence of study related adverse events
monitor the occurrence of study related adverse events
Measured: from the date of recieving intravenous CART cells up to one month
Secondary outcomes (2)
objective response rate
the proportion of patients benefit from the therapy
Measured: 28 days and 3 months after recieving intravenous CART cells
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
Measured: from the date of recieving intravenous CART cells up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start31 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin Lymphoma,B CellStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhihua Yao, PhD, Henan Cancer Hospital
- Investigators
- Zhihua Yao, M.D. Ph.D, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160362
- Sponsor's protocol ID
- Th_C155
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06160362
- Acronym / sponsor ID
- Th_C155
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Keywords
- non-Hodgkin's lymphoma, CART
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| double-target CART-19 and 20 | Experimental | Biological: CART-19 and 20 cells, Drug: Cyclophosphamide, Drug: FludarabinePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CART-19 and 20 cellsDouble-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy. | Biological | double-target CART-19 and 20 |
| Cyclophosphamidepatients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2). | Drug | double-target CART-19 and 20 |
| FludarabineFludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2). | Drug | double-target CART-19 and 20 |
Primary outcome
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
2 secondary outcomes
objective response rate
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhihua Yao, M.D. Ph.D study director
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CART-19 and 20 cells, Cyclophosphamide and Fludarabine in people with Non-hodgkin Lymphoma,B Cell, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihua Yao, M.D. Ph.D (+8613592622292, zlyyyaozhihua1260@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.