Non-Hodgkin's LymphomaEarly Phase 1NCT04028440
γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
A Early Phase 1 study testing Autologous γδT cells in people with Non-Hodgkin's Lymphoma and Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma, Chronic Lymphoblastic Leukemia
- What is being tested?
- Autologous γδT cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- Oct 2019to 31 Mar 2022
- Phase
- Early Phase 1
- 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
- Patients should sign informed consent form voluntarily.
- Gender unlimited, age ≥ 18 years old.
- Patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma(PTCL) expect for γδT lymphoma.
- Patients had an evaluable imaging lesion of at least greater than 1.5 cm (except CLL).
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Adequate bone marrow function as defined by：Absolute neutrophil count (ANC) >1000/mm3；Absolute lymphocyte count (ALC) ≥300/mm3；Platelet ≥50000/mm3；Hemoglobin >8.0g/dl.
- Adequate end organ function as defined by: Total bilirubin ≤ 2 x upper limit of normal（ULN）; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 60ml/min.
- Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
Who cannot join
- Patients with history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- Active central nervous system (CNS) lymphoma; Patients with symptoms of CNS disease must undergo lumbar puncture and brain nuclear magnetic resonance to exclude CNS lymphoma.
- Patients receiving chemotherapy within 2 weeks prior to γδT cell infusion, with the following exceptions:
- Pretreatment chemotherapy prescribed by the protocol
- In order to prevent CNS intrathecal chemotherapy (should be stopped 1 week before γδT cell therapy)
- Other exploratory combined medications
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- Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
- Active chronic hepatitis B or hepatitis C virus infection, active cytomegalovirus (CMV), EBV infection.
- Major surgery that was evaluated by the investigator as unsuitable for inclusion within 4 weeks prior to screening.
- History of other malignant tumors, with the following exceptions
- Excisional non-melanoma (e.g. cutaneous basal cell carcinoma)
- Cured situ carcinoma (e.g. cervical carcinoma)
- Localized prostate cancer with radiotherapy or surgery
- Patients with a history of malignant tumors, but the disease has been cured for ≥2 years
- Patient's cardiac function meets any of the following conditions
- Left ventricular ejection fraction (LVEF) ≤45%
- Class III or IV heart failure according to the NYHA Heart Failure Classifications
- QTcB>450 msec
- Other cardiac disease that investigators judge is not suitable for enrollment
- History of epilepsy or other active central nervous system disorders.
- Inoculated live vaccine within 6 weeks before screening.
- Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia).
- Patients are allergic to cytokines.
- Expected survival < 12 weeks.
- Participated in any other interventional clinical trial within three months.
- Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Dehui Zou, Dr., 86-022-23909283, zoudehui@ihcams.ac.cn
Shuhua Yi, Dr., 86-022-23909106, yishuhua@ihcams.ac.cn
About this study
Official title: Preliminary Exploration of γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL).
This study aims to evaluate the safety and efficacy of autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
Read the detailed description
This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, screening and registration to the trial, apheresis, γδT cells preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatment and follow-up. The study will evaluate the safety and efficacy of the autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
- Conditions
- Non-Hodgkin's Lymphoma, Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma, Chronic Lymphoblastic Leukemia, Peripheral T Cell Lymphoma
- Being tested
- Autologous γδT cells
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence, Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous γδT cellsBiological
Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
| Study group | Role | What they receive |
|---|---|---|
| Autologous γδT cells | Experimental | Subjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions, single infusion intravenously at a target dose of 1~2×10e9 γδT cells (constant dose). Receives: Biological: Autologous γδT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Severe/Adverse Events as a Measure of Safety.
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
Measured: 15 months
Overall response rate (ORR)
Rate of complete remission (CR) and partial remission (PR).
Measured: 28 days after infusion of γδT cells
Secondary outcomes (5)
Duration of remission (DOR)
Duration of remission is defined as the time from the first occurrence of CR or PR in the tumor assessment to the first occurrence of disease progression (PD) or death.
Measured: 15 months
Time to response(TTR)
Time to response is defined as the time from the first administration of trial drug to the first occurrence of CR or PR in the tumor assessment.
Measured: 15 months
Disease control rate (DCR)
Disease control rate is defined as the proportion of subjects who achieved CR, PR, and disease stability (SD) by imaging evaluation.
Measured: 15 months
Progression free survival (PFS)
Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.
Measured: 15 months
Overall survival (OS)
Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study startOct 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Biological: Autologous γδT cells Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing GD Initiative Cell Therapy Technology Co., Ltd., Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Zou Dehui, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Dehui Zou, Dr., Principal investigator, Institute of Hematology & Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028440
- Sponsor's protocol ID
- QT2019001-EC-2
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2019
- Last updated
- 26 Sep 2019
- Results posted
- 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 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Exploration of γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL).
- ClinicalTrials.gov ID
- NCT04028440
- Acronym / sponsor ID
- QT2019001-EC-2
- Conditions
- Non-Hodgkin's Lymphoma, Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma, Chronic Lymphoblastic Leukemia, Peripheral T Cell Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Beijing GD Initiative Cell Therapy Technology Co., Ltd., Chinese Academy of Medical Sciences
- Study start
- Oct 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 22 Jul 2019 (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 aims to evaluate the safety and efficacy of autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
Detailed description
This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, screening and registration to the trial, apheresis, γδT cells preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatment and follow-up. The study will evaluate the safety and efficacy of the autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biological: Autologous γδT cells Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
| Arm | Type | Receives |
|---|---|---|
| Autologous γδT cells | Experimental | Biological: Autologous γδT cellsSubjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions, single infusion intravenously at a target dose of 1~2×10e9 γδT cells (constant dose). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients should sign informed consent form voluntarily.
- Gender unlimited, age ≥ 18 years old.
- Patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma(PTCL) expect for γδT lymphoma.
- Patients had an evaluable imaging lesion of at least greater than 1.5 cm (except CLL).
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
Key exclusion criteria (26 listed)
- Patients with history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- Active central nervous system (CNS) lymphoma; Patients with symptoms of CNS disease must undergo lumbar puncture and brain nuclear magnetic resonance to exclude CNS lymphoma.
- Patients receiving chemotherapy within 2 weeks prior to γδT cell infusion, with the following exceptions:
- Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
- Active chronic hepatitis B or hepatitis C virus infection, active cytomegalovirus (CMV), EBV 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 |
|---|---|---|
| Autologous γδT cellsCells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred. | Biological | Autologous γδT cells |
Primary outcome
Number of Participants with Severe/Adverse Events as a Measure of Safety.
Time frame: 15 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
Overall response rate (ORR)
Time frame: 28 days after infusion of γδT cells
Rate of complete remission (CR) and partial remission (PR).
5 secondary outcomes
Duration of remission (DOR)
Time frame: 15 months
Time to response(TTR)
Time frame: 15 months
Disease control rate (DCR)
Time frame: 15 months
Progression free survival (PFS)
Time frame: 15 months
Overall survival (OS)
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- 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. This study is not recruiting at the moment.
Dehui Zou, Dr. principal investigator
Institute of Hematology & Blood Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous γδT cells in people with Non-Hodgkin's Lymphoma and Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China 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 26 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 26 Sep 2019. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dehui Zou, Dr. (86-022-23909283, zoudehui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Severe/Adverse Events as a Measure of Safety. (time frame: 15 months). The study lists 2 primary outcomes in all. 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 26 Sep 2019.