B-Cell MalignanciesEarly Phase 1NCT03642496
Clinical Study of ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies
A Early Phase 1 study testing Low dose ET019002- T Cells, Middle dose ET019002- T Cells and High dose ET019002- T Cells in people with B-Cell Malignancies, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- B-Cell Malignancies
- What is being tested?
- Low dose ET019002- T Cells, Middle dose ET019002- T Cells and High dose ET019002- T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2018to 20 Sep 2020
- 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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed B cell malignancies including: B-cell Acute Lymphoblastic Leukemia (B-ALL) and B cell lymphomas (DLBCL、FL、MZL、LPL、HCL、CLL、BL、MCL)
- Refractory/Relapsed B cell malignancies:
- Age 6-80 years, male or female
- Nidus could be evaluated: minimum diameter of single nidus ≥10mm, and/or tumor cells in bone marrow ≥ 5%
- ECOG≤2 points
- Function of main organs or tissues were functional: Liver - ALT/AST≤3 normal upper limit, Serum total bilirubin (TBIL) ≤2 normal upper limit; Kidney - glomerular filtration rate (GFR) > 60 mL/min/1.73 m2 or serum creatinine in normal range; Lunge - carbon monoxide diffusion capacity (DLCO) or forced expiratory volume in 1s (FEV) >45% estimate; Heart - left ventricular ejection fraction (LVEF) ≥50%
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- Expecting life span ≥3 months
- No chemotherapy, radiation therapy or immunotherapy in 2 weeks before enrollment
- Fertile females/males consented to use contraceptives during participation of the trial
- Patient or his/her custodia could understand and is willing to sign the written consent
Who cannot join
- Pregnancy or lactation
- Couldn't use contraceptives during participation of the trial
- Couldn't collect enough monocyte
- Active and/or severe infection
- HIV infection, active Hepatitis B or Hepatitis C infection
- Had active autoimmune disease
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- Had non-melanoma skin carcinoma (NMSC) or Carcinoma in situ (e.g. cervix, bladder, galactophore)
- Obvious clinical encephalopathy or novel neuron function damage
- Organ failure: Heart - upper than NYHA level III or had uncontrolled malignant arrhythmia; Liver - upper than level III of Wuhan conference classification; Kidney - kidney failure stage3 or worse
- Using immunosuppressive drugs or adreno-cortical hormone (ACH) within two weeks of enrollment
- Insufficient T cell number or T cell transfection rate
- Needed urgent disease controlling due to tumor load
- Patients had biological treatment, immunotherapy or radiation therapy within 6 weeks prior to enrollment or are currently under these treatment
- Substance abuse or drug addiction
- lack of compliance, communication deficit or other unaccommodated situations
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Clinical Study of Structurally Optimized ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies
This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.
Read the detailed description
ET019002-T cell therapy is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR-T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.The arm of the study is experimental i.v. arm:ET019002-T cells administered by intravenous (IV) infusion.The intervention is ET019002-T cells(Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET019002)-expression construct).
- Conditions
- B-Cell Malignancies
- Being tested
- Low dose ET019002- T Cells, Middle dose ET019002- T Cells, High dose ET019002- T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose ET019002- T CellsBiological
ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 0.75×10*6/kg.
Middle dose ET019002- T CellsBiological
ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 1.5×10*6/kg.
High dose ET019002- T CellsBiological
ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 3.0×10*6/kg.
| Study group | Role | What they receive |
|---|---|---|
| The low dose group | Experimental | Not described Receives: Biological: Low dose ET019002- T Cells |
| The middle dose group | Experimental | Not described Receives: Biological: Middle dose ET019002- T Cells |
| The high dose group | Experimental | Not described Receives: Biological: High dose ET019002- T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET019002T-cells,which is irreversible or life threatening or CTCAE Grade 3-5.
Measured: Up to 12 weeks.
Tmax of serum cytokine levels
Cytokins as measured by CBA-Bioplex Multiplex Immunoassays will be presented as time to peak level.
Measured: Up to 12 weeks.
Time to baseline for serum cytokine levels
Inceases or decreases in the amout of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing.
Measured: Up to 12 weeks.
Toxicity profile of ET019002T-cell treatment
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 ET019002 T cell 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: Up to 2 years.
Secondary outcomes (3)
Rate of disease response
Rate of disease response assessed by lugano cliassification.Response rates will be estimated as CR,PR,SD,PD.
Measured: Up to 12 weeks.
Progression free survival(PFS)
Progression free survival(PFS) denotes the chances of staying free of disease progression for patients after treatment.
Measured: Up to 2 years.
Time to baseline for B cell level
B cell level as measured by Bio-Plex Multiplex Immunoassays will be presented.
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start19 Aug 2018 (estimated)
- Primary completion19 Aug 2020 (estimated)
- Study completion20 Sep 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 B-Cell MalignanciesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Eureka Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- He Peng cheng, Doctor, Principal investigator, First Affiliated Hospital of Xian JiaotongUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642496
- Sponsor's protocol ID
- XJTU1AF2018LSL-C003
- Status last verified
- Jul 2018
- First submitted
- 13 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He P, Liu H, Zimdahl B, Wang J, Luo M, Chang Q, Tian F, Ni F, Yu D, Liu H, Chen L, Wang H, Zhang M, Grupp SA, Liu C. A novel antibody-TCR (AbTCR) T-cell therapy is safe and effective against CD19-positive relapsed/refractory B-cell lymphoma. J Cancer Res Clin Oncol. 2023 Jul;149(7):2757-2769. doi: 10.1007/s00432-022-04132-9. Epub 2022 Jul 1.
PubMed 35776199
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Structurally Optimized ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT03642496
- Acronym / sponsor ID
- XJTU1AF2018LSL-C003
- Conditions
- B-Cell Malignancies
- 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
- 19 Aug 2018 (estimated)
- Primary completion
- 19 Aug 2020 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 22 Aug 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.
This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.
Detailed description
ET019002-T cell therapy is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR-T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.The arm of the study is experimental i.v. arm:ET019002-T cells administered by intravenous (IV) infusion.The intervention is ET019002-T cells(Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET019002)-expression construct).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The low dose group | Experimental | Biological: Low dose ET019002- T Cells |
| The middle dose group | Experimental | Biological: Middle dose ET019002- T Cells |
| The high dose group | Experimental | Biological: High dose ET019002- T Cells |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed B cell malignancies including: B-cell Acute Lymphoblastic Leukemia (B-ALL) and B cell lymphomas (DLBCL、FL、MZL、LPL、HCL、CLL、BL、MCL)
- Refractory/Relapsed B cell malignancies:
- Age 6-80 years, male or female
- Nidus could be evaluated: minimum diameter of single nidus ≥10mm, and/or tumor cells in bone marrow ≥ 5%
- ECOG≤2 points
Key exclusion criteria (15 listed)
- Pregnancy or lactation
- Couldn't use contraceptives during participation of the trial
- Couldn't collect enough monocyte
- Active and/or severe infection
- HIV infection, active Hepatitis B or Hepatitis C 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 |
|---|---|---|
| Low dose ET019002- T CellsET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 0.75×10*6/kg. | Biological | The low dose group |
| Middle dose ET019002- T CellsET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 1.5×10*6/kg. | Biological | The middle dose group |
| High dose ET019002- T CellsET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 3.0×10*6/kg. | Biological | The high dose group |
Primary outcome
Maximum Tolerated Dose
Time frame: Up to 12 weeks.
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET019002T-cells,which is irreversible or life threatening or CTCAE Grade 3-5.
Tmax of serum cytokine levels
Time frame: Up to 12 weeks.
Cytokins as measured by CBA-Bioplex Multiplex Immunoassays will be presented as time to peak level.
Time to baseline for serum cytokine levels
Time frame: Up to 12 weeks.
Inceases or decreases in the amout of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing.
Toxicity profile of ET019002T-cell treatment
Time frame: Up to 2 years.
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 ET019002 T cell 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.
3 secondary outcomes
Rate of disease response
Time frame: Up to 12 weeks.
Progression free survival(PFS)
Time frame: Up to 2 years.
Time to baseline for B cell level
Time frame: Up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Derived from this study: PubMed 35776199He P, Liu H, Zimdahl B, Wang J, Luo M, Chang Q, Tian F, Ni F, Yu D, Liu H, Chen L, Wang H, Zhang M, Grupp SA, Liu C. A novel antibody-TCR (AbTCR) T-cell therapy is safe and effective against CD19-positive relapsed/refractory B-cell lymphoma. J Cancer Res Clin Oncol. 2023 Jul;149(7):2757-2769. doi: 10.1007/s00432-022-04132-9. Epub 2022 Jul 1.
- 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.
He Peng cheng, Doctor principal investigator
First Affiliated Hospital of Xian JiaotongUniversity
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low dose ET019002- T Cells, Middle dose ET019002- T Cells and High dose ET019002- T Cells in people with B-Cell Malignancies, run by First Affiliated Hospital Xi'an Jiaotong University.
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 15 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 He Peng cheng, Doctor (0086-18991232609 ext. He Pengcheng, hepc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: Up to 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 NCT03642496, 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 23 Aug 2018.