LeukemiaPhase 1/2NCT02710149
A Clinical Research of CD20-Targeted CAR-T in B Cell Malignancies
A Phase 1/2 study testing Anti-CD20-CAR-transduced T cells in people with Leukemia and Lymphoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
The main purpose of this study is to explore the therapeutic effect of CD20-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of B cell malignancies. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- What is being tested?
- Anti-CD20-CAR-transduced T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2021
- Phase
- Phase 1/2
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CD20-expressing B cell malignancy must be assured and must be relapsed or refractory disease after at least one standard chemotherapy and one salvage regimen. According to current traditional therapies, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have disease activity that prohibits SCT at this time.
- Patients enrolled must have an evaluated score above 60 with KPS.
- CD20 expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry. In general immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples.
- Gender is not limited, age from 14 years to 75 years.
- Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
- Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
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- Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts.
- Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:
- CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs; CNS 2, defined as presence of < 5/uL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm CNS3 with marrow disease who has failed salvage systemic and intensive IT chemotherapy (and therefore not eligible for radiation)
- Patients with isolated CNS relapse will be eligible if they have previously been treated with cranial radiation (at least 1800 cGy).
- Ability to give informed consent.
- Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
- Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
- Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
- Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- Patients volunteer to participate in the research.
Who cannot join
- Subjects meeting any of the following criteria are not eligible for participation in the study:
- Patients are evaluated below 60 scores with KPS.
- Evident signs suggesting that patients are potentially allergic to cytokines.
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
- Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
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- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- Pregnancy and nursing females.
- HIV infection.
- Active hepatitis B or active hepatitis C.
- Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
- Other situations we think not eligible for participation in the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000
Cheng Qian, PhD, 008615086883400, cqian3184@163.com
Zhi Yang, PhD, 008613206140093
About this study
The main purpose of this study is to explore the therapeutic effect of CD20-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of B cell malignancies.
Read the detailed description
The anti-CD20 antibody has been broadly used in the treatment of B cell malignancies and exhibited good clinical outcomes. The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. However, patients treated with CD19-targeted CAR-T may face relapse of CD19 mutation. Other targets aimed CAR-T is in need. Therefore we constructed CD20-targeted CAR-T cells and hope to start a clinicaltrial to explore the therapeutic effect of CD20-targeted CAR-T cells in the treatment of B cell malignancies.
- Being tested
- Anti-CD20-CAR-transduced T cells
- Keywords
- CAR-T, Leukemia, Lymphoma
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD20-CAR-transduced T cellsBiological
Also called CD20-targeted CAR-T cells
Patients receive autologous-derived CD20-targeted CAR-T cells on day 1, 2 after receiving lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| B Cell Malignancies | Experimental | The trial will be conducted in a manner of simon two-stage design with Anti-CD20-CAR-transduced T cells, beginning in the first stage with the aim of over 30% reaction rate among 15 patients with B cell malignancies. Only when the expected reaction rate is achieved the 30 patients left can be recruited. Receives: Biological: Anti-CD20-CAR-transduced T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events That Are Related to Treatment
Determine the toxicity profile of the CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Measured: 2 years
Secondary outcomes (2)
In vivo existence of Anti-CD20 CAR-T cells
Measured: 2 years
Reaction Rate of Treatment
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 posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiqi Li, Southwest Hospital, China
- Investigators
- Cheng Qian, MD, PhD, Study chair, Biotherapy Center of Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710149
- Sponsor's protocol ID
- TMMU-BTC-003
- Status last verified
- Jun 2019
- First submitted
- 8 Nov 2015
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research of CD20-Targeted CAR-T in B Cell Malignancies
- ClinicalTrials.gov ID
- NCT02710149
- Acronym / sponsor ID
- TMMU-BTC-003
- Keywords
- CAR-T, Leukemia, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 16 Mar 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.
The main purpose of this study is to explore the therapeutic effect of CD20-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of B cell malignancies.
Detailed description
The anti-CD20 antibody has been broadly used in the treatment of B cell malignancies and exhibited good clinical outcomes. The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. However, patients treated with CD19-targeted CAR-T may face relapse of CD19 mutation. Other targets aimed CAR-T is in need. Therefore we constructed CD20-targeted CAR-T cells and hope to start a clinicaltrial to explore the therapeutic effect of CD20-targeted CAR-T cells in the treatment of B cell malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B Cell Malignancies | Experimental | Biological: Anti-CD20-CAR-transduced T cellsThe trial will be conducted in a manner of simon two-stage design with Anti-CD20-CAR-transduced T cells, beginning in the first stage with the aim of over 30% reaction rate among 15 patients with B cell malignancies. Only when the expected reaction rate is achieved the 30 patients left can be recruited. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- CD20-expressing B cell malignancy must be assured and must be relapsed or refractory disease after at least one standard chemotherapy and one salvage regimen. According to current traditional therapies, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have disease activity that prohibits SCT at this time.
- Patients enrolled must have an evaluated score above 60 with KPS.
- CD20 expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry. In general immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples.
- Gender is not limited, age from 14 years to 75 years.
- Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
Key exclusion criteria (14 listed)
- Subjects meeting any of the following criteria are not eligible for participation in the study:
- Patients are evaluated below 60 scores with KPS.
- Evident signs suggesting that patients are potentially allergic to cytokines.
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
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 |
|---|---|---|
| Anti-CD20-CAR-transduced T cellsAlso: CD20-targeted CAR-T cellsPatients receive autologous-derived CD20-targeted CAR-T cells on day 1, 2 after receiving lymphodepleting chemotherapy. | Biological | B Cell Malignancies |
Primary outcome
Adverse Events That Are Related to Treatment
Time frame: 2 years
Determine the toxicity profile of the CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
2 secondary outcomes
In vivo existence of Anti-CD20 CAR-T cells
Time frame: 2 years
Reaction Rate of Treatment
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 25 Jun 2019.
- 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.
Cheng Qian, MD, PhD study chair
Biotherapy Center of Southwest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-CD20-CAR-transduced T cells in people with Leukemia and Lymphoma, run by Southwest Hospital, China 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 16 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: status not confirmed, as of the sponsor's last update on 25 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Cheng Qian, MD, PhD (0086-023-68765461, cqian3184@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events That Are Related to Treatment (time frame: 2 years). 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 25 Jun 2019.