NK CellPhase 1/2NCT05909098
Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma
A Phase 1/2 study testing autologous NK cell in people with NK Cell and B-cell Lymphoma Recurrent, run by Xiangyang No.1 People's Hospital at 1 site in China.
Trial summary
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NK Cell, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory
- What is being tested?
- autologous NK cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
- Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.
- First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
- ECOG scores were 0 to 2
- Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.
- For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years.
- For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.
- Volunteer to participate in the trial and sign the informed consent form.
Who cannot join
- Presence of bone marrow or/and central nervous system lymphoma.
- Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.
- Combined with other malignancies.
- Fever of non-disease-related origin within the last 5 days.
- Presence of uncontrollable bacterial, fungal, viral or other infections.
- Patients with HIV, TP positive
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- Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present.
- Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc.
- Received any form of organ transplantation, including allogeneic stem cell transplantation.
- Presence of a serious psychiatric disorder.
- Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment.
- Pregnant or lactating women.
- The researchers deemed unsuitable for participation in this study. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
EC of Xiangyang No.1 People's Hospital Hubei University of Medicine
Hubei, Xiangyang, 441000
Jiwu He, +86 07103122615, xzyxhgx@163.com
About this study
Official title: Xiangyang No.1 People's Hospital, Hubei University of Medicine
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
Read the detailed description
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
- Being tested
- autologous NK cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous NK cellCombination product
autologous NK cell
| Study group | Role | What they receive |
|---|---|---|
| NK cell | Experimental | autologous NK cell adjuvant therapy Receives: Combination Product: autologous NK cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
Secondary outcomes (10)
CR
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
PR
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
SD
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
PD
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
CBR
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
PFS
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
DOR
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
OS
Refer to the 2014 version of Lugano standard
Measured: up to 5 years of treatment
ECOG
ECOG score Zubrod-ECOG-WHO (ZPS, 5-point scale)
Measured: up to 5 years of treatment
EORTC QLQ-C30
EORTC:The European O-rganization for Reasearch and Treatment of Cancer
Measured: up to 5 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK CellStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangyang No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao Haier Biotechnology Co.,Ltd.
- Responsible party
- Principal investigator, Bin Pei, Xiangyang No.1 People's Hospital
- Investigators
- Bin Pei, Principal investigator, Xiangyang No.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909098
- Sponsor's protocol ID
- Xiangyang1PH
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xiangyang No.1 People's Hospital, Hubei University of Medicine
- ClinicalTrials.gov ID
- NCT05909098
- Acronym / sponsor ID
- Xiangyang1PH
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Xiangyang No.1 People's HospitalUniversity, hospital or other
- Collaborators
- Qingdao Haier Biotechnology Co.,Ltd.
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 18 Jun 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 study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
Detailed description
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK cell | Experimental | Combination Product: autologous NK cellautologous NK cell adjuvant therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
- Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.
- First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
- ECOG scores were 0 to 2
- Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.
Key exclusion criteria (13 listed)
- Presence of bone marrow or/and central nervous system lymphoma.
- Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.
- Combined with other malignancies.
- Fever of non-disease-related origin within the last 5 days.
- Presence of uncontrollable bacterial, fungal, viral or other infections.
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 |
|---|---|---|
| autologous NK cellautologous NK cell | Combination product | NK cell |
Primary outcome
ORR
Time frame: up to 5 years of treatment
Refer to the 2014 version of Lugano standard
10 secondary outcomes
CR
Time frame: up to 5 years of treatment
PR
Time frame: up to 5 years of treatment
SD
Time frame: up to 5 years of treatment
PD
Time frame: up to 5 years of treatment
CBR
Time frame: up to 5 years of treatment
PFS
Time frame: up to 5 years of treatment
DOR
Time frame: up to 5 years of treatment
OS
Time frame: up to 5 years of treatment
ECOG
Time frame: up to 5 years of treatment
EORTC QLQ-C30
Time frame: up to 5 years of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Bin Pei principal investigator
Xiangyang No.1 People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous NK cell in people with NK Cell and B-cell Lymphoma Recurrent, run by Xiangyang No.1 People's 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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 22 Jun 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwu He (+86 07103122615, xzyxhgx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 5 years of treatment). 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 22 Jun 2023.