Relapsed Non Hodgkin LymphomaPhase 2NCT04539444
A Study of CD19/22 CART Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Lymphoma
A Phase 2 study testing CD19/22 CART and Tislelizumab in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- What is being tested?
- CD19/22 CART and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Mar 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- R/R B-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry ( meeting any of the following conditions):
- A.The lesion shrinkage <50% or disease progression after 4 courses of standard first-line treatment or 2 courses of two-line treatment (primary refractory disease) B. Progress disease as the best response after hematopoietic stem cell transplantation C.Progress disease or stable disease as the best response to most recent therapy regimen
- Age ≥ 18 years
- The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
- The main organ functions need to meet the following conditions:
- A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2 upper limitation of normal D.SpO2 > 90%
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- Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
- Expected survival exceeds 3 months
- Written informed consent could be acquired
Who cannot join
- Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
- Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection
- Active hepatitis B or hepatitis C infection
- HIV infection
- Severe acute or chronic graft-versus-host disease (GVHD)
- Participated in any other drug research clinical trials within 30 days before enrollment
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- Prior CART cells therapy within 3 months before enrollment
- Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
- Have contraindications to the PD-1 inhibitors
- Uncontrolled other tumor
- Women in pregnancy,lactation or planning to become pregnant
- The researcher considers inappropriate to participate in this research
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: A Study Evaluated Efficacy and Safety of CD19/22 Chimeric Antigen Receptor T Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.
Read the detailed description
Though response rates have greatly improved with the development of Chimeric antigen receptor T cells (CART) therapy in refractory/relapsed B cell non-Hodgkin's lymphoma (R/R B-NHL), the response can't usually last long and relapse occurs in a large proportion of patients who receive CART cells infusion. The main reasons of relapse might be tumor antigen loss and a lack of CART cell persistence. Currently, preclinical studies have shown that there is a synergistic effect between CAR-T cell therapy and anti-PD1 pathway, and it did have efficacy in clinic. In parallel, the combined use of CART-19 and CART-22 cells has a better potential to reduce antigen escape and increase anti-tumor activity. Therefore, the combination of CD19/22 CART and PD-1 inhibitor is one of the ways to improve the therapeutic effect of CART cells. This study was conducted to explore the efficacy and safety of CD19/22 CART cells in R/R B-NHL.
- Being tested
- CD19/22 CART, Tislelizumab
- Keywords
- Chimeric antigen receptor T cells, Relapsed or refractory B cells non-Hodgkin's lymphoma, PD-1 inhibitor
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/22 CARTBiological
CD19/22 CART cells are administrated in a 3-day split-dose regimen at dose of 0.5- 2×10*107 CART cells per kilogram of body weight.
TislelizumabDrug
Also called PD-1 inhibitor
Patients will receive Tislelizumab 200mg/dose every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CD19/22 CART cells combined with PD-1 inhibitors | Experimental | Patients will receive PD-1 inhibitor on the first day after CART cell infusion Receives: Biological: CD19/22 CART; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Number of patients who achieved response (complete response and partial response ) after treatment of CD19/22 CART combined with PD-1 inhibitor. Response will be assessed using the Lugano criteria.
Measured: 1 year
Progression-free survival(PFS)
PFS will be assessed from the first CART cell infusion to progression,death or last follow-up.
Measured: 1 year
Secondary outcomes (4)
Complete relapse rate(CR)
Number of patients who achieved complete response after treatment by CD19/22 CART combined with PD-1 inhibitor.
Measured: 1 year
Duration of overall response (DOR)
Duration of overall response will be assessed from the first CAR-T cell infusion to progression,death or last follow-up.
Measured: 1 year
Overall survival(OS)
OS will be assessed from the first CART cell infusion to death or last follow-up.
Measured: 1 year
Incidence of treatment-related adverse events
The incidence rate of adverse events from the first day of preconditioning chemotherapy to 1 year after CART cells infusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Aug 2020
- Primary completion30 Sep 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Depei Wu, M.D., Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539444
- Sponsor's protocol ID
- CCPD-1 in lymphoma
- Status last verified
- Jan 2023
- First submitted
- 31 Aug 2020
- Last updated
- 2 Jun 2026
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluated Efficacy and Safety of CD19/22 Chimeric Antigen Receptor T Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT04539444
- Acronym / sponsor ID
- CCPD-1 in lymphoma
- Keywords
- Chimeric antigen receptor T cells, Relapsed or refractory B cells non-Hodgkin's lymphoma, PD-1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 7 Sep 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.
This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.
Detailed description
Though response rates have greatly improved with the development of Chimeric antigen receptor T cells (CART) therapy in refractory/relapsed B cell non-Hodgkin's lymphoma (R/R B-NHL), the response can't usually last long and relapse occurs in a large proportion of patients who receive CART cells infusion. The main reasons of relapse might be tumor antigen loss and a lack of CART cell persistence. Currently, preclinical studies have shown that there is a synergistic effect between CAR-T cell therapy and anti-PD1 pathway, and it did have efficacy in clinic. In parallel, the combined use of CART-19 and CART-22 cells has a better potential to reduce antigen escape and increase anti-tumor activity. Therefore, the combination of CD19/22 CART and PD-1 inhibitor is one of the ways to improve the therapeutic effect of CART cells. This study was conducted to explore the efficacy and safety of CD19/22 CART cells in R/R 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 |
|---|---|---|
| CD19/22 CART cells combined with PD-1 inhibitors | Experimental | Biological: CD19/22 CART, Drug: TislelizumabPatients will receive PD-1 inhibitor on the first day after CART cell infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- R/R B-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry ( meeting any of the following conditions):
- A.The lesion shrinkage <50% or disease progression after 4 courses of standard first-line treatment or 2 courses of two-line treatment (primary refractory disease) B. Progress disease as the best response after hematopoietic stem cell transplantation C.Progress disease or stable disease as the best response to most recent therapy regimen
- Age ≥ 18 years
- The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
- The main organ functions need to meet the following conditions:
Key exclusion criteria (12 listed)
- Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
- Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection
- Active hepatitis B or hepatitis C infection
- HIV infection
- Severe acute or chronic graft-versus-host disease (GVHD)
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 |
|---|---|---|
| CD19/22 CARTCD19/22 CART cells are administrated in a 3-day split-dose regimen at dose of 0.5- 2×10*107 CART cells per kilogram of body weight. | Biological | CD19/22 CART cells combined with PD-1 inhibitors |
| TislelizumabAlso: PD-1 inhibitorPatients will receive Tislelizumab 200mg/dose every 3 weeks. | Drug | CD19/22 CART cells combined with PD-1 inhibitors |
Primary outcome
Overall response rate (ORR)
Time frame: 1 year
Number of patients who achieved response (complete response and partial response ) after treatment of CD19/22 CART combined with PD-1 inhibitor. Response will be assessed using the Lugano criteria.
Progression-free survival(PFS)
Time frame: 1 year
PFS will be assessed from the first CART cell infusion to progression,death or last follow-up.
4 secondary outcomes
Complete relapse rate(CR)
Time frame: 1 year
Duration of overall response (DOR)
Time frame: 1 year
Overall survival(OS)
Time frame: 1 year
Incidence of treatment-related adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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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.
Depei Wu, M.D. study chair
The First Affiliated Hospital of Soochow University
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 CD19/22 CART and Tislelizumab in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by The First Affiliated Hospital of Soochow 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 9 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: finished, as of the sponsor's last update on 2 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 1 year). 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 2 Jun 2026.