Primary Mediastinal B-cell Lymphoma (PMBCL)Phase 1CD19-CARNK/TNCT06464861
Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
A Phase 1 study testing CD19-CAR-NK/T in people with Primary Mediastinal B-cell Lymphoma (PMBCL) and Mantle Cell Lymphoma (MCL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Mediastinal B-cell Lymphoma (PMBCL), Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma( DLBCL)
- What is being tested?
- CD19-CAR-NK/T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 30 Jun 2027
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, no gender limit;
- Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:
- Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ；
- Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;
- Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;
- Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;
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- At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
- The expected survival period is ≥12 weeks;
- The puncture section of the tumor tissue was positive for CD19 expression;
- ECOG score 0-2 points;
- Sufficient organ function reserve:
- Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
- Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
- Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
- Glomerular filtration rate\>50Ml/min
- Cardiac ejection fraction (EF) ≥50%;
- Under natural indoor air environment, basic oxygen saturation\>92%
- Allow a previous stem cell transplantation
- The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;
- Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;
- Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial
- Two tests for the new coronavirus or swine flu virus are negative.
Who cannot join
- Allergic to any of the components of cell products;
- History of other tumors;
- Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;
- Had received gene therapy within the past 3 months;
- Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted;
- Patents infected with hepatitis B (HBsAg positive, but HBV-DNA \< 103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons;
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- Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association\'s cardiac function grading criteria;
- Patients who received antitumor therapy earlier but did not recover from the toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia);
- Subjects with a history of epilepsy or other central nervous system disorders;
- Head-enhanced CT or MRI showing evidence of central nervous system lymphoma;
- Lactating women who are unwilling to stop breastfeeding;
- Any other factors that the investigator believes may increase the risk to the subject or interfere with the test results.
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, 1 recruiting
- Recruiting
the Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Wenbin Qian, Professor, 13605801032, qianwb@zju.edu.cn
Hui Liu, Doctor, sylen@zju.edu.cn
About this study
Official title: Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed/Refractory B Cell Lymphoma
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma
Read the detailed description
This is a single-center, open, single-arm clinical exploratory study to observe the safety and efficacy of cord blood derived CD19 CAR-NK cells sequential treatment with 7x19 CAR-T in relapse / refractory B cell lymphoma. This study consisted of two phases: phase I: CARNK cells preparation and infusion (Day0, dose of 2 x 10^6 / kg). Phase II: 7x19 CAR-T cells preparation and infusion (Day7, dose 2×10^6/kg).
- Conditions
- Primary Mediastinal B-cell Lymphoma (PMBCL), Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma( DLBCL)
- Being tested
- CD19-CAR-NK/T
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-CAR-NK/TBiological
Cord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T
| Study group | Role | What they receive |
|---|---|---|
| CD19-CAR-NK/T | Experimental | All subjects were intravenously administrated with CAR-NK019 at day 0 with a dose of 2x10^6/kg, and after 1 week will be infused with 7x19 CAR-T at the dose of 2x10^6/kg Receives: Biological: CD19-CAR-NK/T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLTs)
To evaluate the safety and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Measured: Up to 28 days
Secondary outcomes (5)
Overall survival (OS)
To determine the OS of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Measured: Up to 2 years
Progression free survival (PFS)
To determine the anti-tumor efficacy of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Measured: Up to 2 years
Duration of response (DOR)
To determine the DOR of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Measured: Up to 2 years
Complete response rate (CR)
To determine the CR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Measured: Up to 2 years
Partial response rate (PR)
To determine the PR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start20 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Mediastinal B-cell Lymphoma (PMBCL)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenbin Wenbin, Professor, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464861
- Sponsor's protocol ID
- 2024 (0673)
- Acronym
- CD19-CARNK/T
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed/Refractory B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06464861
- Acronym / sponsor ID
- CD19-CARNK/T / 2024 (0673)
- Conditions
- Primary Mediastinal B-cell Lymphoma (PMBCL), Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma( DLBCL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Jun 2024 (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 study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma
Detailed description
This is a single-center, open, single-arm clinical exploratory study to observe the safety and efficacy of cord blood derived CD19 CAR-NK cells sequential treatment with 7x19 CAR-T in relapse / refractory B cell lymphoma. This study consisted of two phases: phase I: CARNK cells preparation and infusion (Day0, dose of 2 x 10^6 / kg). Phase II: 7x19 CAR-T cells preparation and infusion (Day7, dose 2×10^6/kg).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19-CAR-NK/T | Experimental | Biological: CD19-CAR-NK/TAll subjects were intravenously administrated with CAR-NK019 at day 0 with a dose of 2x10^6/kg, and after 1 week will be infused with 7x19 CAR-T at the dose of 2x10^6/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 18-75 years old, no gender limit;
- Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:
- Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;
- At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
- The expected survival period is ≥12 weeks;
Key exclusion criteria (12 listed)
- Allergic to any of the components of cell products;
- History of other tumors;
- Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;
- Had received gene therapy within the past 3 months;
- Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted;
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-CAR-NK/TCord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T | Biological | CD19-CAR-NK/T |
Primary outcome
Incidence of dose limiting toxicity (DLTs)
Time frame: Up to 28 days
To evaluate the safety and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
5 secondary outcomes
Overall survival (OS)
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Complete response rate (CR)
Time frame: Up to 2 years
Partial response rate (PR)
Time frame: Up to 2 years
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 7 Feb 2025.
- 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.
Wenbin Wenbin, Professor study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19-CAR-NK/T in people with Primary Mediastinal B-cell Lymphoma (PMBCL) and Mantle Cell Lymphoma (MCL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 22 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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 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.
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 Wenbin Qian, Professor (+8613605801032, qianwb@zju.edu.cn), 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: Up to 28 days). 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 7 Feb 2025.