Objective Response RatePhase 1NCT04850560
Sequential Low-dose Decitabine With PD-1/CD28 CD19 CAR-T in Relapsed or Refractory B-cell Lymphoma
A Phase 1 study testing CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine in people with Objective Response Rate, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To evaluate the efficacy and safety of CD19 PD-1/CD28-CAR-T sequential low-dose decitabine in the treatment of relapse or refractory B cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Objective Response Rate
- What is being tested?
- CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2021to 1 May 2024
- Phase
- 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
- (1) Age ≥ 18, upper limit 75, unlimited for men and women;
- ECOG score 0-3;
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) [according to who 2008];
- CD19 was positive (immunohistochemistry or flow cytometry).
- The definition of refractory or relapse of DLBCL is: no complete remission after 2-line treatment; disease progression in any treatment process, or disease stabilization time equal to or less than 6 months; or disease progression or relapse within 12 months after hematopoietic stem cell transplantation;
- The previous treatment of diffuse large B cell lymphoma must include rituximab (CD20 mAb) and anthracycline;
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- There should be at least one measurable focus. It is required that any length of lymph node focus should be greater than 1.5cm or any length of extranodal focus should be greater than 1.0cm. PET-CT scan focuses should have uptake (SUV is greater than liver blood pool);
- The absolute value of neutrophils in peripheral blood ≥ 1000 / μ L, platelet ≥ 45000 / μ L;
- Heart, liver and kidney function: creatinine < 1.5mg/dl; ALT (alanine aminotransferase) / AST (aspartate aminotransferase) 2.5 times lower than the normal upper limit; total bilirubin < 1.5mg/dl; heart ejection fraction (EF) ≥ 50%;
- Sufficient understanding ability and voluntary signing of informed consent;
- Those with fertility must be willing to use contraceptive methods;
- According to the judgment of the researchers, the expected survival time is more than 4 months;
- Willing to follow visit schedule, administration plan, laboratory inspection and other test steps.
Who cannot join
- (1) History of other tumors;
- Hematopoietic stem cell transplantation was performed within 6 weeks;
- Any target car-t treatment was performed within 3 months before the car-t treatment;
- Previous use of any commercially available PD-1 mAb;
- Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection;
- Active autoimmune diseases;
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- Uncontrollable infection of active bacteria and fungi;
- HIV infection, syphilis infection; active hepatitis B or C: hepatitis B: HBV-DNA ≥ 1000IU / ml; hepatitis C: HCV RNA positive and liver function abnormal.
- Known central nervous system lymphoma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 3100019
Hui Liu
About this study
Official title: Sequential Low-dose Decitabine Therapy With Novel CAR-T Carrying PD-1/CD28 Chimeric Switch Receptor in Relapsed or Refractory B-cell Lymphoma
To evaluate the efficacy and safety of CD19 PD-1/CD28-CAR-T sequential low-dose decitabine in the treatment of relapse or refractory B cell lymphoma.
- Conditions
- Objective Response Rate
- Being tested
- CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 PD-1/CD28 CAR-T Plus Low Dose DecitabineBiological
CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine
| Study group | Role | What they receive |
|---|---|---|
| CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine | Experimental | Not described Receives: Biological: CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate of the combination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start18 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective Response RateStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850560
- Sponsor's protocol ID
- IR2021001123
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 9 Jun 2021
- 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Low-dose Decitabine Therapy With Novel CAR-T Carrying PD-1/CD28 Chimeric Switch Receptor in Relapsed or Refractory B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04850560
- Acronym / sponsor ID
- IR2021001123
- Conditions
- Objective Response Rate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 20 Apr 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.
To evaluate the efficacy and safety of CD19 PD-1/CD28-CAR-T sequential low-dose decitabine in the treatment of relapse or refractory B cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine | Experimental | Biological: CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- (1) Age ≥ 18, upper limit 75, unlimited for men and women;
Key exclusion criteria (9 listed)
- (1) History of other tumors;
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 PD-1/CD28 CAR-T Plus Low Dose DecitabineCD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine | Biological | CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine |
Primary outcome
Objective response rate
Time frame: 3 months
Objective response rate of the combination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- 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 1 study testing CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine in people with Objective Response Rate, 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 13 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 9 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Liu, MD, PhD (13819198629, sylenliu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 3 months). 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 9 Jun 2021.