Lymphoma, B-CellPhase 2NCT03598179
XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
A Phase 2 study testing chimeric antigen receptor T cells in people with Lymphoma, B-Cell and Leukemia, B-cell, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, Leukemia, B-cell
- What is being tested?
- chimeric antigen receptor T cells
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, male and female,
- Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry
- No effective treatment
- Patients must have a measurable or evaluable disease at the time of enrollment.
- Adequate organ system function including:
- ALT/AST < 3 upper limit of normal; Total Bilirubin < 2.5 upper limit of normal
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- Creatinine < 2 upper limit of normal
- Oxygen saturation ≥ 95%
- Left ventricular ejection fraction ≥ 40%
- Number of neutrophil ≥ 0.75×10^9/L, number of platelet ≥ 50×10^9/L
- At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments)
- No contraindications of peripheral blood apheresis
- Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
- ECOG score 0-2, expected survival ≥ 12 weeks
Who cannot join
- Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
- Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons
- Subjects with any autoimmune disease or any immune deficiency disease
- Have a history of allergy to antibodies or cellular products
- Participated in any other clinical trial within four weeks
- Used of systemic steroids within four weeks (using inhaled steroids or ≤ 20mg/d prednison are exceptions)
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- Have mental diseases
- Have history of drug addiction
- The investigators believe that any increase in the risk of the subject or interference with the results of the trial
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjin, Jiangsu, 210029
About this study
Official title: A Single-center, Open Study Evaluating Efficacy and Safety of XLCART001（CD-19） Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects
- Conditions
- Lymphoma, B-Cell, Leukemia, B-cell
- Being tested
- chimeric antigen receptor T cells
- Medical subject headings
- 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.
chimeric antigen receptor T cellsBiological
Dose CAR+ cells/kg B-cell lymphoma 4×10^6 Acute lymphocytic leukemia 2×10^6 Chronic lymphocytic leukemia 10×10^6
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.
Measured: 12 weeks
Overall Survival
from the time of enrollment to death from any cause or the date of the last follow-up visit
Measured: 6 months,1 year, 2 years
Progression-free Survival
the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit
Measured: 12 weeks,6 months,1 year, 2 years
Event-free Survival
the time from enrollment to any events, or the date of the last follow-up visit
Measured: 12 weeks,6 months,1 year, 2 years
Secondary outcomes (3)
Dose-limiting toxicity (DLT)
Non-haematological dose-limiting toxicities was any toxicity of grade 3 or higher occurring within 28 days of XLCART001 infusion judged possibly related to the treatment regimen.The following toxicities were not considered dose limiting toxicities: tumor lysis syndrome, abnormal electrolytes responding to supplementation, hypoalbuminemia, liver dysfunction resolving to ≤grade 2 within 14 days, transient (<72 hours) grade 4 hepatic enzyme abnormality, and grade 3 or 4 fever or neutropenic fever.
Measured: 28 days
Number of CAR-T cells
The number of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction
Measured: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
Duration of CAR-T cells
The duration of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction
Measured: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion1 Jul 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 Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JianYong Li, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598179
- Sponsor's protocol ID
- JSPH-CART001
- Status last verified
- Aug 2019
- First submitted
- 27 Jun 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PubMed 34515338
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Study Evaluating Efficacy and Safety of XLCART001（CD-19） Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
- ClinicalTrials.gov ID
- NCT03598179
- Acronym / sponsor ID
- JSPH-CART001
- Conditions
- Lymphoma, B-Cell, Leukemia, B-cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 26 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 trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years, male and female,
- Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry
- No effective treatment
- Patients must have a measurable or evaluable disease at the time of enrollment.
- Adequate organ system function including:
Key exclusion criteria (9 listed)
- Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
- Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons
- Subjects with any autoimmune disease or any immune deficiency disease
- Have a history of allergy to antibodies or cellular products
- Participated in any other clinical trial within four weeks
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 |
|---|---|---|
| chimeric antigen receptor T cellsDose CAR+ cells/kg B-cell lymphoma 4×10^6 Acute lymphocytic leukemia 2×10^6 Chronic lymphocytic leukemia 10×10^6 | Biological | – |
Primary outcome
Overall response rate
Time frame: 12 weeks
Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.
Overall Survival
Time frame: 6 months,1 year, 2 years
from the time of enrollment to death from any cause or the date of the last follow-up visit
Progression-free Survival
Time frame: 12 weeks,6 months,1 year, 2 years
the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit
Event-free Survival
Time frame: 12 weeks,6 months,1 year, 2 years
the time from enrollment to any events, or the date of the last follow-up visit
3 secondary outcomes
Dose-limiting toxicity (DLT)
Time frame: 28 days
Number of CAR-T cells
Time frame: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
Duration of CAR-T cells
Time frame: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 34515338Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 chimeric antigen receptor T cells in people with Lymphoma, B-Cell and Leukemia, B-cell, run by The First Affiliated Hospital with Nanjing 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 14 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 7 Aug 2019. 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?
Results are not available in the source record.
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 (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 NCT03598179, 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 7 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.