NHLEarly Phase 1NCT04639739
Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma.
A Early Phase 1 study testing anti-CD19 CAR NK in people with NHL, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are limitations of CAR-T cells, the consuming manufacturing time and expensive price exclude the majority of patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NHL
- What is being tested?
- anti-CD19 CAR NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2020to 1 Dec 2023
- 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
None listed.
Who cannot join
- Any of the following points shall be deemed as no entry into this study：
- Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years)；
- Severe mental disorders；
- A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
- History of allogeneic stem cell transplantation；
- Heart disease with grade III-IV heart failure [NYHA classification], myocardial infarction, angioplasty or stenting, unstable angina or other heart diseases with prominent clinical symptoms within one year before admission；
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- Subjects with any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, bile drainage tube or pleura/peritoneum/pericardium catheter), should be excluded. (Special central venous catheter is allowed)；
- Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis；
- Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS；
- Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg；
- Active infection requiring systematic treatment within 2 weeks before single collection；
- Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy；
- History of autoimmune diseases (e.g. Crohn disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end-organ damage or require systemic immunosuppressive medications or systemic disease modifying drugs in the past 2 years；
- Presence of pulmonary fibrosis；
- Subjects who have received other clinical trial treatment within 4 weeks before participating in this trial should be excluded. Or the signing date of informed consent is within 5 half-lives of the last application of another clinical trial (whichever is longer)；
- Subjects with poor compliance due to physiological, family, social, geographical and other factors, or those unable to cooperate with the study plan or follow-up； At the discretion of the investigator, there are complications requiring systemic corticosteroid therapy (≥ 5mg / day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs within 6 months after this clinical research treatment；
- The lactating woman who is reluctant to stop breastfeeding；
- Any other condition considered unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
About this study
Official title: Anti-CD19 CAR NK Cell Therapy for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma: a Multi-center, Uncontrolled Trial.
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are limitations of CAR-T cells, the consuming manufacturing time and expensive price exclude the majority of patients. therefore, we designed this trial to manifest the safety and efficacy of anti-CD19 CAR NK cell therapy in non-Hodgkin lymphoma
- Conditions
- NHL
- Being tested
- anti-CD19 CAR NK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR NKBiological
2×106 /kg、6×106 /kg、2×107/kg Treatment follows a lymphodepletion, the recommended chemotherapy regimen consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) for 3 days prior to cell infusion，the actual regiment is determined by the statue of patients.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19 CAR NK cells | Experimental | The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determined optimal dosage. Receives: Biological: anti-CD19 CAR NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLTs)
To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Measured: within 4 weeks after infusion
Incidence and severity of AEs and SAEs
To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Measured: Up to 24 months
Secondary outcomes (3)
The overall response rate(ORR)
to characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Measured: 1 and 3 months after infusion
progression-free survival (PFS)
to characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Measured: 1, 3, 6, 12 and 24 months after infusion
overall survival(OS)
to characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Measured: 1, 3, 6, 12 and 24 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start17 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Responsible party
- Principal investigator, Xi Zhang, MD, Xinqiao Hospital of Chongqing
- Investigators
- Xi Zhang, Study chair, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639739
- Sponsor's protocol ID
- CAR NK for NHL
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-CD19 CAR NK Cell Therapy for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma: a Multi-center, Uncontrolled Trial.
- ClinicalTrials.gov ID
- NCT04639739
- Acronym / sponsor ID
- CAR NK for NHL
- Conditions
- NHL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Study start
- 17 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 20 Nov 2020 (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.
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are limitations of CAR-T cells, the consuming manufacturing time and expensive price exclude the majority of patients. therefore, we designed this trial to manifest the safety and efficacy of anti-CD19 CAR NK cell therapy in non-Hodgkin lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19 CAR NK cells | Experimental | Biological: anti-CD19 CAR NKThe study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determined optimal dosage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Any of the following points shall be deemed as no entry into this study：
- Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years)；
- Severe mental disorders；
- A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
- History of allogeneic stem cell transplantation；
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 |
|---|---|---|
| anti-CD19 CAR NK2×106 /kg、6×106 /kg、2×107/kg Treatment follows a lymphodepletion, the recommended chemotherapy regimen consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) for 3 days prior to cell infusion，the actual regiment is determined by the statue of patients. | Biological | anti-CD19 CAR NK cells |
Primary outcome
Incidence of dose limiting toxicity (DLTs)
Time frame: within 4 weeks after infusion
To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Incidence and severity of AEs and SAEs
Time frame: Up to 24 months
To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
3 secondary outcomes
The overall response rate(ORR)
Time frame: 1 and 3 months after infusion
progression-free survival (PFS)
Time frame: 1, 3, 6, 12 and 24 months after infusion
overall survival(OS)
Time frame: 1, 3, 6, 12 and 24 months after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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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.
Xi Zhang study chair
Xinqiao Hospital of Chongqing
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 anti-CD19 CAR NK in people with NHL, run by Xinqiao Hospital of Chongqing 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 0 inclusion and 18 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 20 Nov 2020. 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 Xi Zhang, MD phD (13808310064 ext. +86, zhangxxi@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLTs) (time frame: within 4 weeks after infusion). 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 20 Nov 2020.