Relapsed or Refractory B-cell LymphomasPhase 1NCT03576807
The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma
A Phase 1 study testing CD20 CAR-T cells in people with Relapsed or Refractory B-cell Lymphomas, run by Xin Wang at 1 site in China.
Trial summary
The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Relapsed or Refractory B-cell Lymphomas
- What is being tested?
- CD20 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2018to 3 Apr 2020
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1．Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation.
- 2.The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%.
- 5. Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications.
- 9.ECOG评分≤2. 10. Patients need to sign informed consent.
Who cannot join
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
- Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.);
- The patient is an active hepatitis B or hepatitis C infection.
- The patient received genetic product treatment within six months.
- The patient participated in a clinical trial within six months.
- The patient has a severe autoimmune disease.
- The doctor thinks that there are other reasons that can't be accepted.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Kailin K Xu, DOCTOR, +86 0516 85802398, lihmd@163.com
Jiang Cao, DOCTOR, +86 13852432263, zimu05067@163.com
About this study
The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.
Read the detailed description
The main purpose:
To preliminary explore the safety, tolerability and cellular pharmacokinetics of CD20-CART cell agents in the treatment of relapsed or refractory B-cell lymphomas.
The Secondary purpose:
The following indicators for preliminary observations of CD20-CART cells in the treatment of relapsed or refractory B-cell malignant lymphoma.
- The determination of lymph nodes to evaluate the anti-tumor effect caused by the input of CD20-CART cells agents.
- Assessing the ability of CD20-CART cell agents to inhibit the migration of bone marrow and lymph node tumor foci.
- Assess the killing ability of CD20-CART cell agents to tumor cells in vitro, for patients whose tumor cells could obtain.
- Disease control rate (DCR) (=CR (complete disease remission) + PR (partial remission of disease) + SD (stable disease), short-term efficacy assessment); Overall survival (OS) and progression-free survival (PFS) (long-term efficacy assessment).
- Conditions
- Relapsed or Refractory B-cell Lymphomas
- Being tested
- CD20 CAR-T cells
- Keywords
- B-cell leukemia
- Medical subject headings
- Recurrence, Lymphoma, B-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD20 CAR-T cellsDrug
A total of 1 - 20×10^6 CD20 CAR-T cells/kg will be administered by IV infusions.
| Study group | Role | What they receive |
|---|---|---|
| CD20 CAR-T cells | Experimental | Experimental: CD20 CAR-T cells Receives: Drug: CD20 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study related adverse events [ Time Frame: 4 weeks ]
Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible.
Measured: 4 weeks
Secondary outcomes (1)
Graft Activity Endpoint Detection
The PCR method was used to detect the copy number of the exogenous CAR vector in the blood until the end of the test was negative for both tests.
Measured: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start4 Apr 2018
- Primary completion3 Apr 2019 (estimated)
- Study completion3 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell LymphomasStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Wang, Shanghai Longyao Biotechnology Inc., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576807
- Sponsor's protocol ID
- SHLY1701
- Status last verified
- Apr 2018
- First submitted
- 21 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma
- ClinicalTrials.gov ID
- NCT03576807
- Acronym / sponsor ID
- SHLY1701
- Conditions
- Relapsed or Refractory B-cell Lymphomas
- Keywords
- B-cell leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xin WangUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 3 Apr 2019 (estimated)
- Study completion
- 3 Apr 2020 (estimated)
- First posted
- 3 Jul 2018 (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.
The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.
Detailed description
The main purpose:
To preliminary explore the safety, tolerability and cellular pharmacokinetics of CD20-CART cell agents in the treatment of relapsed or refractory B-cell lymphomas.
The Secondary purpose:
The following indicators for preliminary observations of CD20-CART cells in the treatment of relapsed or refractory B-cell malignant lymphoma.
- The determination of lymph nodes to evaluate the anti-tumor effect caused by the input of CD20-CART cells agents.
- Assessing the ability of CD20-CART cell agents to inhibit the migration of bone marrow and lymph node tumor foci.
- Assess the killing ability of CD20-CART cell agents to tumor cells in vitro, for patients whose tumor cells could obtain.
- Disease control rate (DCR) (=CR (complete disease remission) + PR (partial remission of disease) + SD (stable disease), short-term efficacy assessment); Overall survival (OS) and progression-free survival (PFS) (long-term efficacy assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD20 CAR-T cells | Experimental | Drug: CD20 CAR-T cellsExperimental: CD20 CAR-T cells |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 1．Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation.
- 2.The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%.
- 5. Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications.
- 9.ECOG评分≤2. 10. Patients need to sign informed consent.
Key exclusion criteria (7 listed)
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
- Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.);
- The patient is an active hepatitis B or hepatitis C infection.
- The patient received genetic product treatment within six months.
- The patient participated in a clinical trial within six months.
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 |
|---|---|---|
| CD20 CAR-T cellsA total of 1 - 20×10^6 CD20 CAR-T cells/kg will be administered by IV infusions. | Drug | CD20 CAR-T cells |
Primary outcome
Study related adverse events [ Time Frame: 4 weeks ]
Time frame: 4 weeks
Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible.
1 secondary outcome
Graft Activity Endpoint Detection
Time frame: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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 CD20 CAR-T cells in people with Relapsed or Refractory B-cell Lymphomas, run by Xin Wang 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 4 inclusion and 7 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 3 Jul 2018. 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 JIANG CAO, DOCTOR (+86 1385243263, zimu05067@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study related adverse events [ Time Frame: 4 weeks ] (time frame: 4 weeks). 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 3 Jul 2018.