CD19+ Lymphoma, B-CellEarly Phase 1NCT03895944
ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and Lymphoma
A Early Phase 1 study testing ET190L1-ARTEMIS™ T cells -iv low dose, ET190L1-ARTEMIS™ T cells -iv middle dose and ET190L1-ARTEMIS™ T cells - iv high dose in people with CD19+ Lymphoma, B-Cell and CD19+ Leukemia, B-Cell, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CD19+ Lymphoma, B-Cell, CD19+ Leukemia, B-Cell
- What is being tested?
- ET190L1-ARTEMIS™ T cells -iv low dose, ET190L1-ARTEMIS™ T cells -iv middle dose and ET190L1-ARTEMIS™ T cells - iv high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2017to 6 Dec 2019
- Phase
- Early 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
- Patients with relapsed/refractory CD19+ B-cell lymphoma or Leukemia, with no effective therapy available per National Comprehensive Cancer Network (NCCN) guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2, expected survival time > 3 months per PIs opinion
- Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose.
- Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
- serum alanine aminotransferase(ALT)<200 Unit/L, ALT/Aspartate aminotransferase(AST)<3 normal range; serum creatinine (Cr)<2.5mg/dL
- Voluntarily signed informed consent form
Who cannot join
- Women in pregnancy and lactation
- Unable to perform leukapheresis and iv infusion
- With active infection
- Major organ failure
- Patients with dependence on corticosteroids
- Continuously used glucocorticoids or other immunosuppressive agents within 2 weeks
- T cell deficiency or T cells are difficult to be transduced
- Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Mei Zhang, PhD, 86-18991232153, prozhangmei@126.com
About this study
Official title: Phase 1, Open-label, Single-arm, Dose-escalation Clinical Study Evaluating the Safety and Efficacy of ET190L1-ARTEMIS™2 in Relapsed, Refractory B Cell Leukemia and Lymphoma
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma
Read the detailed description
ARTEMIS™ is a novel chimeric T-cell therapy that in pre-clinical studies, functionally matches the efficacy of Chimeric Antigen Receptor (CAR) T cells, but dramatically reduces the release of cytokines upon killing of target positive tumors. The molecular target for ET190L1-ARTEMIS™ is Cluster of Differentiation 19 (CD19), which is expressed on B cell Lymphomas and B cell Leukemias. ET190L1-ARTEMIS™ is a second generation ARTEMIS™ receptor engineered with a human Fab antibody domain against CD19. This clinical study evaluates the safety and pharmacokinetics of ET190L1-ARTEMIS™ T-cells in patients with relapsed/refractory B-cell lymphoma and B-cell Leukemia.
- Conditions
- CD19+ Lymphoma, B-Cell, CD19+ Leukemia, B-Cell
- Being tested
- ET190L1-ARTEMIS™ T cells -iv low dose, ET190L1-ARTEMIS™ T cells -iv middle dose, ET190L1-ARTEMIS™ T cells - iv high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET190L1-ARTEMIS™ T cells -iv low doseBiological
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10^6
ET190L1-ARTEMIS™ T cells -iv middle doseBiological
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10^6
ET190L1-ARTEMIS™ T cells - iv high doseBiological
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10^6
| Study group | Role | What they receive |
|---|---|---|
| iv low dose | Experimental | Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with low dose (1x10^6) in Leukemia or Lymphoma patients Receives: Biological: ET190L1-ARTEMIS™ T cells -iv low dose |
| iv middle dose | Experimental | Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with middle dose (3x10^6) in Leukemia or Lymphoma patients Receives: Biological: ET190L1-ARTEMIS™ T cells -iv middle dose |
| iv high dose | Experimental | Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with high dose (10x10^6) in Leukemia or Lymphoma patients Receives: Biological: ET190L1-ARTEMIS™ T cells - iv high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ARTEMIS T cell treatment-related adverse events
Frequency of treatment-related adverse events that occurred at any time from the first day of infusion that are "possibly", "likely", or "definitely" related to the study, including infusion related toxicity and ET190L1-ARTEMIS™ T T cells related toxicity. Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
Measured: until 24 weeks
Number of ET190L1-ARTEMIS™ T cells in peripheral blood
Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. Number of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on.
Measured: 24 months
% of ET190L1-ARTEMIS™ T cells in peripheral blood
Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. % of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on.
Measured: 24 months
Maximum Tolerated Dose
Determine the safety, including potential dose limiting toxicities, of the ET190L1-ARTEMIS™ T cells. A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET190L1-ARTEMIS™ T cells, which is irreversible or life threatening or CTCAE Grade 3-5. Assessed at all visits.
Measured: 28 days up to 2 years
Secondary outcomes (9)
Tmax of serum cytokine levels
Increase or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immunoassays will be presented as time to peak level.
Measured: 24 weeks
Time to baseline for serum cytokine levels
Increase or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immunoassays will be presented as time to baseline.
Measured: 24 weeks
AUC of serum cytokine levels
Increase or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immunoassays will be presented as area under curve (AUC).
Measured: 24 weeks
Rate of disease response
Rate of disease response assessed by Lugano classification (a lymphoma staging classification). Response rates will be estimated as the percent of patients with any of the following: complete remission (CR), partial response (PR).
Measured: 28 days to 24 months
Progression free survival (PFS)
Progression free survival (PFS)
Measured: 4 months, 1 year and 2 years
Median Survival（MS）
Median Survival（MS）
Measured: 4 months, 1 year and 2 years
Overall Survival（OS）
Overall Survival（OS）
Measured: 4 months, 1 year and 2 years
B cell depletion (Number)
Number of B cells in peripheral blood will be presented as time to baseline level and time to recover for up to 2 years.
Measured: 2 years
B cell depletion (%)
% of B cells in peripheral blood will be presented as time to baseline level and time to recover for up to 2 years.
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 posted29 Mar 2019
- Study start6 Dec 2017
- Primary completion6 Dec 2019 (estimated)
- Study completion6 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19+ Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eureka Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Mei Zhang, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895944
- Sponsor's protocol ID
- XJTU1AF2017LSL-C001
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label, Single-arm, Dose-escalation Clinical Study Evaluating the Safety and Efficacy of ET190L1-ARTEMIS™2 in Relapsed, Refractory B Cell Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT03895944
- Acronym / sponsor ID
- XJTU1AF2017LSL-C001
- Conditions
- CD19+ Lymphoma, B-Cell, CD19+ Leukemia, B-Cell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Eureka Therapeutics Inc.
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 6 Dec 2019 (estimated)
- Study completion
- 6 Dec 2019 (estimated)
- First posted
- 29 Mar 2019 (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.
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma
Detailed description
ARTEMIS™ is a novel chimeric T-cell therapy that in pre-clinical studies, functionally matches the efficacy of Chimeric Antigen Receptor (CAR) T cells, but dramatically reduces the release of cytokines upon killing of target positive tumors. The molecular target for ET190L1-ARTEMIS™ is Cluster of Differentiation 19 (CD19), which is expressed on B cell Lymphomas and B cell Leukemias. ET190L1-ARTEMIS™ is a second generation ARTEMIS™ receptor engineered with a human Fab antibody domain against CD19. This clinical study evaluates the safety and pharmacokinetics of ET190L1-ARTEMIS™ T-cells in patients with relapsed/refractory B-cell lymphoma and B-cell Leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iv low dose | Experimental | Biological: ET190L1-ARTEMIS™ T cells -iv low doseAutologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with low dose (1x10^6) in Leukemia or Lymphoma patients |
| iv middle dose | Experimental | Biological: ET190L1-ARTEMIS™ T cells -iv middle doseAutologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with middle dose (3x10^6) in Leukemia or Lymphoma patients |
| iv high dose | Experimental | Biological: ET190L1-ARTEMIS™ T cells - iv high doseAutologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with high dose (10x10^6) in Leukemia or Lymphoma patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with relapsed/refractory CD19+ B-cell lymphoma or Leukemia, with no effective therapy available per National Comprehensive Cancer Network (NCCN) guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2, expected survival time > 3 months per PIs opinion
- Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose.
- Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
- serum alanine aminotransferase(ALT)<200 Unit/L, ALT/Aspartate aminotransferase(AST)<3 normal range; serum creatinine (Cr)<2.5mg/dL
Key exclusion criteria (8 listed)
- Women in pregnancy and lactation
- Unable to perform leukapheresis and iv infusion
- With active infection
- Major organ failure
- Patients with dependence on corticosteroids
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 |
|---|---|---|
| ET190L1-ARTEMIS™ T cells -iv low doseAutologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10^6 | Biological | iv low dose |
| ET190L1-ARTEMIS™ T cells -iv middle doseAutologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10^6 | Biological | iv middle dose |
| ET190L1-ARTEMIS™ T cells - iv high doseAutologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10^6 | Biological | iv high dose |
Primary outcome
Frequency of ARTEMIS T cell treatment-related adverse events
Time frame: until 24 weeks
Frequency of treatment-related adverse events that occurred at any time from the first day of infusion that are "possibly", "likely", or "definitely" related to the study, including infusion related toxicity and ET190L1-ARTEMIS™ T T cells related toxicity. Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
Number of ET190L1-ARTEMIS™ T cells in peripheral blood
Time frame: 24 months
Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. Number of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on.
% of ET190L1-ARTEMIS™ T cells in peripheral blood
Time frame: 24 months
Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. % of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on.
Maximum Tolerated Dose
Time frame: 28 days up to 2 years
Determine the safety, including potential dose limiting toxicities, of the ET190L1-ARTEMIS™ T cells. A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET190L1-ARTEMIS™ T cells, which is irreversible or life threatening or CTCAE Grade 3-5. Assessed at all visits.
9 secondary outcomes
Tmax of serum cytokine levels
Time frame: 24 weeks
Time to baseline for serum cytokine levels
Time frame: 24 weeks
AUC of serum cytokine levels
Time frame: 24 weeks
Rate of disease response
Time frame: 28 days to 24 months
Progression free survival (PFS)
Time frame: 4 months, 1 year and 2 years
Median Survival（MS）
Time frame: 4 months, 1 year and 2 years
Overall Survival（OS）
Time frame: 4 months, 1 year and 2 years
B cell depletion (Number)
Time frame: 2 years
B cell depletion (%)
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 29 Mar 2019.
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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.
Mei Zhang, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ET190L1-ARTEMIS™ T cells -iv low dose, ET190L1-ARTEMIS™ T cells -iv middle dose and ET190L1-ARTEMIS™ T cells - iv high dose in people with CD19+ Lymphoma, B-Cell and CD19+ Leukemia, B-Cell, run by First Affiliated Hospital Xi'an Jiaotong 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 6 inclusion and 8 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 29 Mar 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Mei Zhang, PhD (86-18991232153, prozhangmei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of ARTEMIS T cell treatment-related adverse events (time frame: until 24 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?
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 29 Mar 2019.