B Cell LeukemiaPhase 2NCT04605666
CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies
A Phase 2 study testing CD19-CAR-T2 Cells in people with B Cell Leukemia and B Cell Lymphoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- B Cell Leukemia, B Cell Lymphoma
- What is being tested?
- CD19-CAR-T2 Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status <2
- ALT/ AST <3 x normal
- Bilirubin < 2.0 mg/dl
- Creatinine < 2.5 mg/dl and less than 2.5x normal for age
- LVEF< 45%
- Accept white blood cell collection
- Provide informed consent
Who cannot join
- Previous treatment with investigational gene or cell therapy medicine products
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Presence of grade 2-4 acute or extensive chronic GVHD
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- Received non-diagnostic purposes major surgery within the past 4 weeks
Show all 14Show fewer
- Participated in any other clinical study within the past 4 weeks
- Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
- Pregnancy or breast-feeding women
- Use of prohibited drugs:
- Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
- Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion
- GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion
- Any situation that may increase the risk of the test or interfere with the test results
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Relapsed/Refractory B Cell Leukemia/Lymphoma
Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).
- Conditions
- B Cell Leukemia, B Cell Lymphoma
- Being tested
- CD19-CAR-T2 Cells
- Keywords
- CAR-T
- Medical subject headings
- Leukemia, B-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-CAR-T2 CellsBiological
CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T group | Experimental | Not described Receives: Biological: CD19-CAR-T2 Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Measured: 3 months
Secondary outcomes (5)
ORR
Measured: 6 months
ORR
Measured: 12 months
Adverse Events
Measured: 12 months
OS
overall survival
Measured: 1 year
DFS
disease-free survival
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 posted28 Oct 2020
- Study start1 May 2020
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
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 B Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qi-fa Liu, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605666
- Sponsor's protocol ID
- NFEC-2020-098
- Other IDs
- NFEC-2020-098
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2020
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He B, Lin R, Xu N, Qin L, Wang Z, Wang Q, Li X, Wei X, Wei Y, Tang Z, Fan Z, Huang F, Liu X, Sun J, Xuan L, Li P, Zhou H, Liu Q. Efficacy and safety of third-generation CD19-CAR T cells incorporating CD28 and TLR2 intracellular domains for B-cell malignancies with central nervous system involvement: results of a pivotal trial. J Transl Med. 2025 May 27;23(1):594. doi: 10.1186/s12967-025-06608-x.
PubMed 40426201
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Relapsed/Refractory B Cell Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT04605666
- Acronym / sponsor ID
- NFEC-2020-098
- Conditions
- B Cell Leukemia, B Cell Lymphoma
- Keywords
- CAR-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Oct 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.
Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (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 |
|---|---|---|
| CAR-T group | Experimental | Biological: CD19-CAR-T2 Cells |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status <2
- ALT/ AST <3 x normal
- Bilirubin < 2.0 mg/dl
- Creatinine < 2.5 mg/dl and less than 2.5x normal for age
Key exclusion criteria (14 listed)
- Previous treatment with investigational gene or cell therapy medicine products
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Presence of grade 2-4 acute or extensive chronic GVHD
- Any uncontrolled active medical disorder that would preclude participation as outlined.
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-T2 CellsCD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0. | Biological | CAR-T group |
Primary outcome
ORR
Time frame: 3 months
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
5 secondary outcomes
ORR
Time frame: 6 months
ORR
Time frame: 12 months
Adverse Events
Time frame: 12 months
OS
Time frame: 1 year
DFS
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 20 Aug 2024.
- Derived from this study: PubMed 40426201He B, Lin R, Xu N, Qin L, Wang Z, Wang Q, Li X, Wei X, Wei Y, Tang Z, Fan Z, Huang F, Liu X, Sun J, Xuan L, Li P, Zhou H, Liu Q. Efficacy and safety of third-generation CD19-CAR T cells incorporating CD28 and TLR2 intracellular domains for B-cell malignancies with central nervous system involvement: results of a pivotal trial. J Transl Med. 2025 May 27;23(1):594. doi: 10.1186/s12967-025-06608-x.
- 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.
Qi-fa Liu, MD principal investigator
Nanfang Hospital, Southern Medical 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-CAR-T2 Cells in people with B Cell Leukemia and B Cell Lymphoma, run by Nanfang Hospital, Southern Medical 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 8 inclusion and 14 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 20 Aug 2024. 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?
ORR (time frame: 3 months). 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 NCT04605666, 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 20 Aug 2024.