Lymphoma, B-CellPhase 1/2NCT04715217
Targeting CD19 and CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory B Cell Lymphoma
A Phase 1/2 study testing CD19-CD22 CAR-T cells in people with Lymphoma, B-Cell, run by Shanxi Province Cancer Hospital at 1 site in China.
Trial summary
Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of B cell lymphoma. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- CD19-CD22 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2021to 31 Oct 2025
- Phase
- Phase 1/2
- 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 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 6-70 - year - old male or female subjects (including 6 years old and 70 years old, 6-18 subjects use only the recommended dose of treatment);
- The Clinical diagnosis of recurrent/refractory B cell lymphoma, after at least 2 courses of treatment, has not been achieved partial response, still in the continuous phase and progress, including the MRD positive, or recurrent intramedullary patients；
- Bone marrow samples inspection by using flow cytometry or organization pathology ，the cell membrane surface antigen CD19 and/or CD22 positive；
- Patients with lymphoma need to have a measurable lesions, measurable target lesions: lymph node x1.0 > 1.5 cm, outside the junction lesions > x1.0 1.0 cm;
- ECOG physical status score of 0 to 2 points;
- Expected lifetime is more than 12 weeks;
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- The clinical laboratory test results of screening phase meet the following criteria: (7 days before the inspection without blood transfusion) Hb≥60 g/L (allowed to use recombinant human erythropoietin); PLT≥ 50 x 10 ^ 9 / L ; ALC≥0.3×10^9/L; ANC≥0.75×10^9/L (allowed to use granulocyte colony stimulating factor); AST≤3ULN,ALT≤3ULN,TBIL≤2ULN；Ccr≥30 mL/min/1.73 m2；
- Cardiopulmonary function: left ventricular ejection fraction > 40%; Baseline blood oxygen saturation > 95%;
- Has a history of allogeneic/allogeneic hematopoietic stem cell transplantation patients: transplantation in 3 months ago, no grade 2 or more active graft versus host disease (GVHD), more than a month without immune inhibitors.
Who cannot join
- The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive subjects; Early syphilis screening antibody positive;
- The other clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection;
- Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure;
- In past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs;
- Had a history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis,etc which influence the appraising of test,;
- Diagnosed with other active malignancy in past five years(the basal or scaly skin cancer, superficial bladder cancer, breast cancer in situ, which has been cured and does not require follow-up treatment are not included );
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- Known allergic to cyclophosphamide, fluorine dara marina or CAR - T cell s including accessories, DMSO ;
- Patients with pregnancy or lactation, patients do not want to take effective contraceptive measures within 6months after infusion CAR-T cells;
- The other situations that researchers determined doesn't fit to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematology Department of ShanXi Cancer Hospital
Taiyuan, Shanxi, 030013
Tao Guan, PhD, +8613509717461, 395714554@qq.com
About this study
Official title: A Clinical Study to Evaluate the Safety and Effectiveness of CD19-CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory B Cell Lymphoma
Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of B cell lymphoma.
Read the detailed description
A non randomized study ,plans to enrollment 24 subjects of B cell lymphoma .The subjects will divide into low, medium and high dose groups，to evaluate the safety and tolerability of CD19-CD22 CAR - T cells，to evaluate the preliminary efficacy and observe PK/PD parameters of CD19-CD22 CAR -T cells immunotherapy in patients with relapsed or refractory B cell lymphoma .
- Conditions
- Lymphoma, B-Cell
- Being tested
- CD19-CD22 CAR-T cells
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-CD22 CAR-T cellsBiological
Also called Fluorine dara marina injection, Cyclophosphamide injection
A autologous doping CAR - T cells injection targets with CD19 and CD22，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion CD19-CD22 CAR-T cells .
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Group | Experimental | CD19-CD22 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 0.5×10^6 CAR+T cells/kg. Receives: Biological: CD19-CD22 CAR-T cells |
| Middle Dose Group | Experimental | CD19-CD22 CAR-T cells injection, infused only once,3-6 subjects of middle dose group will be intravenously infuse with 2.0×10^6 CAR+Tcells/kg. Receives: Biological: CD19-CD22 CAR-T cells |
| High Dose Group | Experimental | CD19-CD22 CAR-T cells injection, infused only once,3-6 subjects of high dose group will be intravenously infuse with 5.0×10^6 CAR+Tcells/kg. Receives: Biological: CD19-CD22 CAR-T cells |
| Amplification Dose Group | Experimental | CD19-CD22 CAR-T cells injection, infused only once.After determined maximum tolerated dose,15 subjects of amplification dose group will be intravenously infuse with 0.5-5.0×10^6 CAR+Tcells/kg. Receives: Biological: CD19-CD22 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Observe wether dose limiting toxicity will happened in dose escalation phase
Measured: Form infusion CAR-T cells to 28 days after infusion
ORR
The overall response rate after CD19-CD22 CAR-T Cells immunotherapy
Measured: Form infusion CAR-T cells to 2 years after infusion
Secondary outcomes (12)
Incidence of various types of adverse recation
According to CTCAE 5.0, record the level , type of adverse events, evaluat the correlation of CD19-CD22 CAR-T cells
Measured: Form infusion CAR-T cells to 2 years after infusion
PFS
Progression-free surial
Measured: Form infusion CAR-T cells to 2 years after infusion
DOR
Duration of Response
Measured: Form infusion CAR-T cells to 2 years after infusion
OS
Overall survival
Measured: Form infusion CAR-T cells to subjects died，assessed up to 60 months
Cmax
By measuring the CAR - T cells copy number and the positive rate, peak plasma concentration is determined
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Tmax
The maximum concentration of time
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
AUC（0-720d）
Area under the plasma concentration versus time curve
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL2 level
The levels of cytokines（IL2 ）in peripheral blood
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL6 level
The levels of cytokines（IL6 ）in peripheral blood
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL10 level
The levels of cytokines（ IL10 ）in peripheral blood
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of TNF-α level
The levels of cytokines（TNF-α）in peripheral blood
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IFN-γ level
The levels of cytokines（IFN-γ ）in peripheral blood
Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start4 Jan 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Liping Su, M.D., Principal investigator, Hematology Department of ShanXi Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715217
- Sponsor's protocol ID
- CAR-T SXZL01
- Status last verified
- Dec 2023
- First submitted
- 7 Jan 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share Clinical Study Report within six months after the study completed
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Effectiveness of CD19-CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04715217
- Acronym / sponsor ID
- CAR-T SXZL01
- Conditions
- Lymphoma, B-Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Collaborators
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 20 Jan 2021 (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.
Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of B cell lymphoma.
Detailed description
A non randomized study ,plans to enrollment 24 subjects of B cell lymphoma .The subjects will divide into low, medium and high dose groups，to evaluate the safety and tolerability of CD19-CD22 CAR - T cells，to evaluate the preliminary efficacy and observe PK/PD parameters of CD19-CD22 CAR -T cells immunotherapy in patients with relapsed or refractory B cell lymphoma .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose Group | Experimental | Biological: CD19-CD22 CAR-T cellsCD19-CD22 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 0.5×10^6 CAR+T cells/kg. |
| Middle Dose Group | Experimental | Biological: CD19-CD22 CAR-T cellsCD19-CD22 CAR-T cells injection, infused only once,3-6 subjects of middle dose group will be intravenously infuse with 2.0×10^6 CAR+Tcells/kg. |
| High Dose Group | Experimental | Biological: CD19-CD22 CAR-T cellsCD19-CD22 CAR-T cells injection, infused only once,3-6 subjects of high dose group will be intravenously infuse with 5.0×10^6 CAR+Tcells/kg. |
| Amplification Dose Group | Experimental | Biological: CD19-CD22 CAR-T cellsCD19-CD22 CAR-T cells injection, infused only once.After determined maximum tolerated dose,15 subjects of amplification dose group will be intravenously infuse with 0.5-5.0×10^6 CAR+Tcells/kg. |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 6-70 - year - old male or female subjects (including 6 years old and 70 years old, 6-18 subjects use only the recommended dose of treatment);
- The Clinical diagnosis of recurrent/refractory B cell lymphoma, after at least 2 courses of treatment, has not been achieved partial response, still in the continuous phase and progress, including the MRD positive, or recurrent intramedullary patients；
- Bone marrow samples inspection by using flow cytometry or organization pathology ，the cell membrane surface antigen CD19 and/or CD22 positive；
- Patients with lymphoma need to have a measurable lesions, measurable target lesions: lymph node x1.0 > 1.5 cm, outside the junction lesions > x1.0 1.0 cm;
- ECOG physical status score of 0 to 2 points;
Key exclusion criteria (9 listed)
- The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive subjects; Early syphilis screening antibody positive;
- The other clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection;
- Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure;
- In past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs;
- Had a history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis,etc which influence the appraising of test,;
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 |
|---|---|---|
| CD19-CD22 CAR-T cellsAlso: Fluorine dara marina injection, Cyclophosphamide injectionA autologous doping CAR - T cells injection targets with CD19 and CD22，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion CD19-CD22 CAR-T cells . | Biological | Amplification Dose Group, High Dose Group, Low Dose Group, Middle Dose Group |
Primary outcome
DLT
Time frame: Form infusion CAR-T cells to 28 days after infusion
Observe wether dose limiting toxicity will happened in dose escalation phase
ORR
Time frame: Form infusion CAR-T cells to 2 years after infusion
The overall response rate after CD19-CD22 CAR-T Cells immunotherapy
12 secondary outcomes
Incidence of various types of adverse recation
Time frame: Form infusion CAR-T cells to 2 years after infusion
PFS
Time frame: Form infusion CAR-T cells to 2 years after infusion
DOR
Time frame: Form infusion CAR-T cells to 2 years after infusion
OS
Time frame: Form infusion CAR-T cells to subjects died，assessed up to 60 months
Cmax
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Tmax
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
AUC（0-720d）
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL2 level
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL6 level
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL10 level
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of TNF-α level
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IFN-γ level
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Yes. Plan to Share Clinical Study Report within six months after the study completed
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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.
Liping Su, M.D. principal investigator
Hematology Department of ShanXi Cancer 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 CD19-CD22 CAR-T cells in people with Lymphoma, B-Cell, run by Shanxi Province 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 9 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 29 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liping Su, M.D. (+8613835158122, sulp2005@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Form infusion CAR-T cells to 28 days 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 29 Dec 2023.