LeukemiaPhase 1/2NCT02537977
CD19-directed CAR T Cells Therapy in Relapsed/Refractory B Cell Malignancy
A Phase 1/2 study testing CD19-directed CAR-T cells in people with Leukemia and Lymphoma, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. Read more about this study
- Who is it for?
- Ages 6 to 85 years
- What is being tested?
- CD19-directed CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jun 2020
- Phase
- Phase 1/2
- 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 6 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CD19+ leukemia or lymphoma, meeting the following criteria:
- At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
- Less than 1 year between last chemotherapy and progression
- Not eligible or appropriate for allo-HSCT
- To be aged 6 to 85 years
- Estimated survival of ≥ 6 months, but ≤ 2 years
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- ECOG score ≤2
- Relapse after auto-HSCT
- Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time
- Voluntary participation in the clinical trials and sign the informed consent
Who cannot join
- History of epilepsy or other CNS disease
- Patients have GVHD, which needs treatment with immunosuppressive agents
- Patients with prolonged QT interval or severe heart disease
- Patients in pregnancy or breast-feeding period
- Uncontrolled active infection
- Active hepatitis B or hepatitis C infection
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- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
- Previously treatment with any gene therapy products
- Feasibility assessment during screening demonstrates <20% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
- ALT /AST>3 x normal value; Creatinine> 2.5 mg/dl; Bilirubin >2.0 mg/dl
- Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
- HIV infection
- Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, 200065
Aibin Liang, MD,Ph.D., 0086-021-66111019, lab7182@tongji.edu.cn
About this study
Official title: CD19-directed Chimeric Antigen Receptor T Cells Therapy in Relapsed/Refractory B Cell Malignancy
Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
Read the detailed description
Tongji Hospital of Tongji University has developed an investigational approach for treating patients with CD19 positive B cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack CD19 positive cells, and then giving the cells back to the patients.The main purpose of the study is to assess the safety and efficacy of the treatment with anti-CD19 CAR-T cells in the patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
- Being tested
- CD19-directed CAR-T cells
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-directed CAR-T cellsBiological
CD19-directed CAR-T cell infusion will be given by vein
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells | Experimental | Autologous 2nd generation CD19-directed CAR-T cells Receives: Biological: CD19-directed CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of study related adverse events
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly，likely，or definitely related to the study.
Measured: 2 years
Secondary outcomes (4)
Response rates to CAR-T cells
Describe the response rates of patients treated with CAR-T cells, including complete remission, partial remission,stable disease and progression disease
Measured: 2 years
Progression free survival(PFS)
Measured: 2 years
Duration of remission(DOR)
Measured: 2 years
Overall survival(OS) of patients treated with CAR-T cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Aibin Liang, MD,Ph.D., Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537977
- Sponsor's protocol ID
- TJ1537
- Status last verified
- Nov 2018
- First submitted
- 26 Aug 2015
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hou M, Zhang W, Qi Z, Li G, Mei H, Qi S, Jin R, Zhao Y, Tang X, Xiu B, Chen X, Zhao Y, Hu C, Qian C, Li X, Xu Z, Chen Y, Wu C, Wang B, Yan L, Li D, Huang Y, Liang R, Wang A, Liu J, Wang W, Li B, Long J, Li P, Liang A, Liu Q, Yang J. Timosaponin AIII enhances CAR-T cell potency and prevents relapse through impairing CAR-Tregs. Nat Commun. 2026 Mar 31;17(1):3045. doi: 10.1038/s41467-026-70867-5.
PubMed 41916982
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19-directed Chimeric Antigen Receptor T Cells Therapy in Relapsed/Refractory B Cell Malignancy
- ClinicalTrials.gov ID
- NCT02537977
- Acronym / sponsor ID
- TJ1537
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 2 Sep 2015 (estimated)
- 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.
Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
Detailed description
Tongji Hospital of Tongji University has developed an investigational approach for treating patients with CD19 positive B cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack CD19 positive cells, and then giving the cells back to the patients.The main purpose of the study is to assess the safety and efficacy of the treatment with anti-CD19 CAR-T cells in the patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
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 cells | Experimental | Biological: CD19-directed CAR-T cellsAutologous 2nd generation CD19-directed CAR-T cells |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with CD19+ leukemia or lymphoma, meeting the following criteria:
- To be aged 6 to 85 years
- Estimated survival of ≥ 6 months, but ≤ 2 years
- ECOG score ≤2
- Relapse after auto-HSCT
Key exclusion criteria (13 listed)
- History of epilepsy or other CNS disease
- Patients have GVHD, which needs treatment with immunosuppressive agents
- Patients with prolonged QT interval or severe heart disease
- Patients in pregnancy or breast-feeding period
- Uncontrolled active infection
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-directed CAR-T cellsCD19-directed CAR-T cell infusion will be given by vein | Biological | CAR-T cells |
Primary outcome
Occurrence of study related adverse events
Time frame: 2 years
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly，likely，or definitely related to the study.
4 secondary outcomes
Response rates to CAR-T cells
Time frame: 2 years
Progression free survival(PFS)
Time frame: 2 years
Duration of remission(DOR)
Time frame: 2 years
Overall survival(OS) of patients treated with CAR-T cells
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Derived from this study: PubMed 41916982Hou M, Zhang W, Qi Z, Li G, Mei H, Qi S, Jin R, Zhao Y, Tang X, Xiu B, Chen X, Zhao Y, Hu C, Qian C, Li X, Xu Z, Chen Y, Wu C, Wang B, Yan L, Li D, Huang Y, Liang R, Wang A, Liu J, Wang W, Li B, Long J, Li P, Liang A, Liu Q, Yang J. Timosaponin AIII enhances CAR-T cell potency and prevents relapse through impairing CAR-Tregs. Nat Commun. 2026 Mar 31;17(1):3045. doi: 10.1038/s41467-026-70867-5.
- 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.
Aibin Liang, MD,Ph.D. principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19-directed CAR-T cells in people with Leukemia and Lymphoma, run by Shanghai Tongji Hospital, Tongji 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 10 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 3 Dec 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 combined 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.
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?
Contact Aibin Liang, MD,Ph.D. (0086-021-66111019, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of study related adverse events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537977, which also lists 1 linked publication.
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 Dec 2018; AzTrials last refreshed its copy on 2 Nov 2026.