B-cell Non Hodgkin LymphomaPhase 2NCT05744037
Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
A Phase 2 study testing regimen with BTK inhibitor +Anti-CD19 CAR T cells in people with B-cell Non Hodgkin Lymphoma, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-cell Non Hodgkin Lymphoma
- What is being tested?
- regimen with BTK inhibitor +Anti-CD19 CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Phase 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients or their legal guardians voluntarily participate and sign the informed consent;
- Male or female patients aged 18-70 years old;
- CD19+ B-NHL was confirmed by pathology and histology, and the patient had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19 CAR T as salvage therapy;
- Subjects showed residual lesions after major treatment and were not suitable for HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk factors; Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy;
- Have measurable or evaluable lesions;
- The patient's main tissues and organs function well;
- The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous drip.
- Patients with ECOG score ≤2, estimated survival time ≥3 months, age ≥ 12 years, ≤ 75 years.
Who cannot join
- Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding;
- Men or women who have planned to get pregnant within the last 1 year;
- The patients were not guaranteed to take effective contraceptive measures (condom or contraceptive, etc.) within 1 year after enrollment;
- Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
- Active hepatitis B/C virus;
- HIV-infected patients;
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- Suffering from a serious autoimmune disease or immunodeficiency disease;
- The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;
- The patient had participated in other clinical trials within 6 weeks prior to enrollment;
- Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
- Suffering from mental illness;
- The patient has substance abuse/addiction;
- According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Wei Sang, M.D., Ph.D., 13645207648, xyfylbl515@xzhmu.edu.cn
About this study
Official title: Prospective, Multicenter, Open, One-arm Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.
Read the detailed description
The most successful application of CAR-T cell technology in clinical practice is for the treatment of hematologic malignancies, which may be related to the strong specificity of tumor-associated antigen and the weak immunosuppressive effect of tumor microenvironment. CD19 is specifically expressed in B cells and is expressed in all stages of B-cell development and differentiation and in most B-cell tumors, but not in hematopoietic stem cells and other cells. CD19 is a promising target for B-cell tumors and is currently a hot spot in CAR studies.
Antigen-dependent BCR signaling is involved in several downstream pathways, including NF-kB pathway and PI3K/AKT/mTOR pathway, which can promote B cell survival. BTK inhibitors can jointly inhibit the survival of tumor cells by promoting apoptosis and inhibiting the proliferation of tumor cells, reducing the adhesion of tumor cells, and inhibiting chemokines to prevent the migration of B cells.
In this study, BTKi (Ibrutinib) combined with Anti-CD19 CAR-T cells were proposed to treat RR B-NHL, with the main purpose of observing the efficacy and safety of this regimen in patients with relapsed and refractory B-NHL.
- Conditions
- B-cell Non Hodgkin Lymphoma
- Being tested
- regimen with BTK inhibitor +Anti-CD19 CAR T cells
- Keywords
- BTK inhibitor, Anti CD19 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.
regimen with BTK inhibitor +Anti-CD19 CAR T cellsBiological
After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Cell Infusion | Experimental | After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd. Receives: Biological: regimen with BTK inhibitor +Anti-CD19 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
CR+PR
Measured: From 1 month to 1 year.
Secondary outcomes (3)
Percentage of complete response
Percentage of complete response
Measured: From 1 month to 1 year.
Progression-free survival
The time between treatment and observation of disease progression or death from any cause.
Measured: From 1 month to 1 year.
Duration of response
Duration of response
Measured: From 1 month to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non Hodgkin LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744037
- Sponsor's protocol ID
- XYFY2022-KL365-02
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 24 Feb 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open, One-arm Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
- ClinicalTrials.gov ID
- NCT05744037
- Acronym / sponsor ID
- XYFY2022-KL365-02
- Conditions
- B-cell Non Hodgkin Lymphoma
- Keywords
- BTK inhibitor, Anti CD19 CAR-T cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Feb 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.
To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.
Detailed description
The most successful application of CAR-T cell technology in clinical practice is for the treatment of hematologic malignancies, which may be related to the strong specificity of tumor-associated antigen and the weak immunosuppressive effect of tumor microenvironment. CD19 is specifically expressed in B cells and is expressed in all stages of B-cell development and differentiation and in most B-cell tumors, but not in hematopoietic stem cells and other cells. CD19 is a promising target for B-cell tumors and is currently a hot spot in CAR studies.
Antigen-dependent BCR signaling is involved in several downstream pathways, including NF-kB pathway and PI3K/AKT/mTOR pathway, which can promote B cell survival. BTK inhibitors can jointly inhibit the survival of tumor cells by promoting apoptosis and inhibiting the proliferation of tumor cells, reducing the adhesion of tumor cells, and inhibiting chemokines to prevent the migration of B cells.
In this study, BTKi (Ibrutinib) combined with Anti-CD19 CAR-T cells were proposed to treat RR B-NHL, with the main purpose of observing the efficacy and safety of this regimen in patients with relapsed and refractory B-NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T Cell Infusion | Experimental | Biological: regimen with BTK inhibitor +Anti-CD19 CAR T cellsAfter FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients or their legal guardians voluntarily participate and sign the informed consent;
- Male or female patients aged 18-70 years old;
- CD19+ B-NHL was confirmed by pathology and histology, and the patient had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19 CAR T as salvage therapy;
- Subjects showed residual lesions after major treatment and were not suitable for HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk factors; Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy;
- Have measurable or evaluable lesions;
Key exclusion criteria (13 listed)
- Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding;
- Men or women who have planned to get pregnant within the last 1 year;
- The patients were not guaranteed to take effective contraceptive measures (condom or contraceptive, etc.) within 1 year after enrollment;
- Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
- Active hepatitis B/C virus;
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 |
|---|---|---|
| regimen with BTK inhibitor +Anti-CD19 CAR T cellsAfter FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd. | Biological | CAR-T Cell Infusion |
Primary outcome
objective response rate
Time frame: From 1 month to 1 year.
CR+PR
3 secondary outcomes
Percentage of complete response
Time frame: From 1 month to 1 year.
Progression-free survival
Time frame: From 1 month to 1 year.
Duration of response
Time frame: From 1 month to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing regimen with BTK inhibitor +Anti-CD19 CAR T cells in people with B-cell Non Hodgkin Lymphoma, run by The Affiliated Hospital of Xuzhou Medical University 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: status not confirmed, as of the sponsor's last update on 24 Feb 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 phase mean?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: From 1 month to 1 year.). 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 24 Feb 2023.