Lymphoma, B CellPhase 4NCT02992834
Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma
A Phase 4 study testing IL-2 pre-treated CD19 cells and IL-7/IL-15 pre-treated CD19 cells in people with Lymphoma, B Cell, run by jiangjingting at 1 site in China.
Trial summary
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, B Cell
- What is being tested?
- IL-2 pre-treated CD19 cells and IL-7/IL-15 pre-treated CD19 cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jan 2022
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment for enough male or female patients with CD19+ hematological malignancies, without regimens for cure (autologous or allogeneic stem cell transplantation), and having a poor prognosis (several months to 2 years) under current optional regimens
- Age ranges from 18 to 70 years old
- Expected survival time longer than 12 weeks
- Performance status score 0-2
- Pathologically confirmed CD19+ lymphoma (CD19+ follicular lymphoma, Mantle cell lymphoma, diffuse large B cell lymphoma) and meets at least one of follows:
- having received at least 2-4 cycles of combined chemotherapy (excluding monoclonal antibody monotherapy, such as rituximab) but do not reach a complete response; recurrent disease; not applicable for conventional stem cell transplantation; being partial responsible or stable but not complete responsible after the latest therapy
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- recurrence develops after stem cell transplantation
- diagnosis confirmed but refusing to receive conventional therapy
- Creatinine<2.5 mg/dl；
- alanine aminotransferase/aspartate aminotransferase lower than 3 folds of normal range
- Bilirubin<2.0 mg/dl；
- Venous channel available and no contraindications for leukocyte collection
- Reliable contraception from the beginning to 30 days after discontinuation of therapy
- Informed consent signed
Who cannot join
- Central nerve system invasion with symptoms
- Other concurrent uncontrolled malignancies
- Hepatitis B infection or active period of hepatitis C, HIV infection
- Other uncontrolled diseases hampering the intervention in the study
- Coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious cardiovascular or cerebrovascular diseases.
- Grade 2-3 or uncontrolled hypertension
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- History of uncontrolled mental disease
- Not suitable for participation judged by researchers
- Immunosuppressive agents administered due to organ transplantation, not including recent or current inhaled corticosteroid
- Medical history of mental diseases or abnormities of lab tests might increase the risks of participation in study or drug administration, or interfering the results
- Screening suggesting transfection efficiency of targeting cells lower than 30% or cell expansion deficiency under CD3/CD28 (cluster of differentiation 3,CD3)stimulation (less than 5 folds)
- Unstable pulmonary embolism, deep venous thromboembolism or other major arterial/venous thromboembolism events develop in 30 days before the randomization. If anti-coagulation therapy is received, the treatment dose should reach stability before the randomization.
- Pregnancy or lactation, or pregnancy planned during the study or in 2 months after the study
- Reliable contraception not accepted during the study or in 2 months after the study. Female subjects are required to provide negative results from serum or urine pregnancy test 48 hours before therapy
- Systematic active or uncontrolled infection (excluding infection of urinary tract or upper respiratory tract infection) in 14 days before the randomization
- Informed consent not signed or study rules violated
Trial locations and contacts
1 site in 1 country.
Jingting Jiang, Professor contact
China1 site
First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
Qi Zhou, Doctor, dr_qzhou@163.com
About this study
Official title: Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for Chemotherapy-resistant or Refractory CD19+B Cell Lymphoma:a Double-arm, Single Center, Open-label Clinical Trial
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma.
Read the detailed description
This is a single-centre, randomised, open label Phase I clinical trial of CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma. Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma.
- Conditions
- Lymphoma, B Cell
- Being tested
- IL-2 pre-treated CD19 cells, IL-7/IL-15 pre-treated CD19 cells
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2 pre-treated CD19 cellsBiological
IL-2 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
IL-7/IL-15 pre-treated CD19 cellsBiological
IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
| Study group | Role | What they receive |
|---|---|---|
| IL-2 pre-treated CD19 cells | Active comparator | Initial therapy: IL-2 (interleukin,IL)stimulated, CD28-ζ-vector (cluster of differentiation 28,CD28)transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion Receives: Biological: IL-2 pre-treated CD19 cells |
| IL-7/IL-15 pre-treated CD19 cells | Active comparator | Initial therapy: IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion Receives: Biological: IL-7/IL-15 pre-treated CD19 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 year
Secondary outcomes (2)
progression-free survival
Measured: 56 day
Objective Response Rate
Measured: 56 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2020 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, B CellStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- jiangjingting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, jiangjingting, The First People's Hospital of Changzhou
- Investigators
- Jingting Jiang, Professor, Principal investigator, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992834
- Sponsor's protocol ID
- CAAA
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rafiq S, Purdon TJ, Daniyan AF, Koneru M, Dao T, Liu C, Scheinberg DA, Brentjens RJ. Optimized T-cell receptor-mimic chimeric antigen receptor T cells directed toward the intracellular Wilms Tumor 1 antigen. Leukemia. 2017 Aug;31(8):1788-1797. doi: 10.1038/leu.2016.373. Epub 2016 Dec 7.
PubMed 27924074Minagawa K, Jamil MO, Al-Obaidi M, Pereboeva L, Salzman D, Erba HP, Lamb LS, Bhatia R, Mineishi S, Di Stasi A. In Vitro Pre-Clinical Validation of Suicide Gene Modified Anti-CD33 Redirected Chimeric Antigen Receptor T-Cells for Acute Myeloid Leukemia. PLoS One. 2016 Dec 1;11(12):e0166891. doi: 10.1371/journal.pone.0166891. eCollection 2016.
PubMed 27907031
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for Chemotherapy-resistant or Refractory CD19+B Cell Lymphoma:a Double-arm, Single Center, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT02992834
- Acronym / sponsor ID
- CAAA
- Conditions
- Lymphoma, B Cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- jiangjingtingUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 14 Dec 2016 (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.
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma.
Detailed description
This is a single-centre, randomised, open label Phase I clinical trial of CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma. Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-2 pre-treated CD19 cells | Active comparator | Biological: IL-2 pre-treated CD19 cellsInitial therapy: IL-2 (interleukin,IL)stimulated, CD28-ζ-vector (cluster of differentiation 28,CD28)transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion |
| IL-7/IL-15 pre-treated CD19 cells | Active comparator | Biological: IL-7/IL-15 pre-treated CD19 cellsInitial therapy: IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Enrollment for enough male or female patients with CD19+ hematological malignancies, without regimens for cure (autologous or allogeneic stem cell transplantation), and having a poor prognosis (several months to 2 years) under current optional regimens
- Age ranges from 18 to 70 years old
- Expected survival time longer than 12 weeks
- Performance status score 0-2
- Pathologically confirmed CD19+ lymphoma (CD19+ follicular lymphoma, Mantle cell lymphoma, diffuse large B cell lymphoma) and meets at least one of follows:
Key exclusion criteria (16 listed)
- Central nerve system invasion with symptoms
- Other concurrent uncontrolled malignancies
- Hepatitis B infection or active period of hepatitis C, HIV infection
- Other uncontrolled diseases hampering the intervention in the study
- Coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious cardiovascular or cerebrovascular diseases.
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 |
|---|---|---|
| IL-2 pre-treated CD19 cellsIL-2 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion | Biological | IL-2 pre-treated CD19 cells |
| IL-7/IL-15 pre-treated CD19 cellsIL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion | Biological | IL-7/IL-15 pre-treated CD19 cells |
Primary outcome
overall survival
Time frame: 5 year
2 secondary outcomes
progression-free survival
Time frame: 56 day
Objective Response Rate
Time frame: 56 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Background: PubMed 27924074Rafiq S, Purdon TJ, Daniyan AF, Koneru M, Dao T, Liu C, Scheinberg DA, Brentjens RJ. Optimized T-cell receptor-mimic chimeric antigen receptor T cells directed toward the intracellular Wilms Tumor 1 antigen. Leukemia. 2017 Aug;31(8):1788-1797. doi: 10.1038/leu.2016.373. Epub 2016 Dec 7.
- Background: PubMed 27907031Minagawa K, Jamil MO, Al-Obaidi M, Pereboeva L, Salzman D, Erba HP, Lamb LS, Bhatia R, Mineishi S, Di Stasi A. In Vitro Pre-Clinical Validation of Suicide Gene Modified Anti-CD33 Redirected Chimeric Antigen Receptor T-Cells for Acute Myeloid Leukemia. PLoS One. 2016 Dec 1;11(12):e0166891. doi: 10.1371/journal.pone.0166891. eCollection 2016.
- 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.
Jingting Jiang, Professor contact
Jingting Jiang, Professor principal investigator
The First People's Hospital of Changzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IL-2 pre-treated CD19 cells and IL-7/IL-15 pre-treated CD19 cells in people with Lymphoma, B Cell, run by jiangjingting 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 16 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 14 Dec 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jingting Jiang, Professor (jjtnew@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 year). 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 NCT02992834, which also lists 2 linked publications.
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 14 Dec 2016.