Recurrent Adult Diffuse Large Cell LymphomaPhase 1MendCARTNCT02721407
Anti-CD22 CAR-T Therapy for CD19-refractory or Resistant Lymphoma Patients
A Phase 1 study testing Retroviral vector-transduced autologous T cells to express CD22-specific CARs in people with Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Follicular Lymphoma, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent Mantle Cell Lymphoma
- What is being tested?
- Retroviral vector-transduced autologous T cells to express CD22-specific CARs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2019
- Phase
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 Years to 70 Years, Male and female;
- 2.Expected survival > 12 weeks;
- 3.Performance score 0-2;
- 4.Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions;
- Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
- Disease recurrence after stem cell transplantation;
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- Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
- 5.Creatinine < 2.5 mg/dl;
- 6.ALT/AST < 3x normal;
- 7.Bilirubin < 2.0 mg/dl;
- 8.Adequate venous access for apheresis, and no other contraindications for leukapheresis;
- 9.Take contraceptive measures before recruit to this trial;
- 10.Written voluntary informed consent is given.
- 11.Refractory ot resistant to prior anti-CD19 CAR-Ts
- 12.At least one evaluable CD22-positive recurrent lesion, confirmed by two independent pathologist.
Who cannot join
- Patients with symptoms of central nervous system
- Accompanied by other malignant tumor
- Active hepatitis B or C, HIV infection
- Any other diseases could affect the outcome of this trial
- Suffering severe cardiovascular or respiratory disease
- Poorly controlled hypertension
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- A history of mental illness and poorly controlled
- Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
- Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
- Reaching a steady dose if receiving anticoagulant therapy before assignment
- Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- Pregnant or lactating women
- Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
Qingzhu Jia, MD, 152-2333-4184 ext. +86, jiaqinghzu0801@outlook.com
About this study
Official title: A Phase I Study of Anti-CD22:TCRz:4-1BB T-cells in Patient With CD22-Positive Recurrent Lymphoma That is Resistant or Refractory to Prior Anti-CD22:TCRz:CD28 Immunotherapy
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs combine the variable region of an antibody with T-cell signaling moieties to confer T-cell activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to MHC down regulation by tumors. However, defined by the recession of evaluable lesions, the persistence and efficacy of CAR-T cells are still restricted by the "target" selection. Previous clinical studies largely utilized CD19 for the in vivo targeting of CAR-T cells, which preferentially become refractory or resistant due to the heterogeneity of lymphoma. This clinical investigation is to test a hypothesis whether anti-CD22 CAR-T cells work more effective in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells.
Read the detailed description
Primary Objectives
- To determine the safety of CD22.CAR-T cells in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells
- To determine in vivo dynamics and persistency of CD22.CAR-T cells.
Secondary Objectives
- To determine the feasibility of CD22.CAR-T cells in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells
- To determine in vivo dynamics and persistency of CD22.CAR-T cells.
- To assess the intratumoral infiltration of CD22.CAR-T cells.
- To correlate the subsets and differentiation of CD22.CAR-T cells to observed anti-tumor efficacy
- Conditions
- Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Stage III/IV Adult Diffuse Large Cell Lymphoma, Stage III/IV Follicular Lymphoma, Stage III/IV Mantle Cell Lymphoma
- Being tested
- Retroviral vector-transduced autologous T cells to express CD22-specific CARs
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroviral vector-transduced autologous T cells to express CD22-specific CARsDrug
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD22 CAR-T | Experimental | Administrated with CD22.CAR-T cells on day 0,1,2 in the lympho-depleted patients Receives: Drug: Retroviral vector-transduced autologous T cells to express CD22-specific CARs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Measured: 4 Weeks
Secondary outcomes (3)
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Measured: 8 Weeks
Duration of CAR-positive T cells in circulation
Measured: 6 months
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adult Diffuse Large Cell LymphomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Xuzhou Medical University
- Responsible party
- Principal investigator, Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721407
- Sponsor's protocol ID
- CD22CART
- Acronym
- MendCART
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Anti-CD22:TCRz:4-1BB T-cells in Patient With CD22-Positive Recurrent Lymphoma That is Resistant or Refractory to Prior Anti-CD22:TCRz:CD28 Immunotherapy
- ClinicalTrials.gov ID
- NCT02721407
- Acronym / sponsor ID
- MendCART / CD22CART
- Conditions
- Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Stage III/IV Adult Diffuse Large Cell Lymphoma, Stage III/IV Follicular Lymphoma, Stage III/IV Mantle Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Xuzhou Medical University
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 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 goal of this clinical trial is to study the feasibility and efficacy of anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs combine the variable region of an antibody with T-cell signaling moieties to confer T-cell activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to MHC down regulation by tumors. However, defined by the recession of evaluable lesions, the persistence and efficacy of CAR-T cells are still restricted by the "target" selection. Previous clinical studies largely utilized CD19 for the in vivo targeting of CAR-T cells, which preferentially become refractory or resistant due to the heterogeneity of lymphoma. This clinical investigation is to test a hypothesis whether anti-CD22 CAR-T cells work more effective in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells.
Detailed description
Primary Objectives
- To determine the safety of CD22.CAR-T cells in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells
- To determine in vivo dynamics and persistency of CD22.CAR-T cells.
Secondary Objectives
- To determine the feasibility of CD22.CAR-T cells in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells
- To determine in vivo dynamics and persistency of CD22.CAR-T cells.
- To assess the intratumoral infiltration of CD22.CAR-T cells.
- To correlate the subsets and differentiation of CD22.CAR-T cells to observed anti-tumor efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CD22 CAR-T | Experimental | Drug: Retroviral vector-transduced autologous T cells to express CD22-specific CARsAdministrated with CD22.CAR-T cells on day 0,1,2 in the lympho-depleted patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1.18 Years to 70 Years, Male and female;
- 2.Expected survival > 12 weeks;
- 3.Performance score 0-2;
- 4.Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions;
- Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
Key exclusion criteria (13 listed)
- Patients with symptoms of central nervous system
- Accompanied by other malignant tumor
- Active hepatitis B or C, HIV infection
- Any other diseases could affect the outcome of this trial
- Suffering severe cardiovascular or respiratory disease
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 |
|---|---|---|
| Retroviral vector-transduced autologous T cells to express CD22-specific CARs | Drug | Anti-CD22 CAR-T |
Primary outcome
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 4 Weeks
3 secondary outcomes
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time frame: 8 Weeks
Duration of CAR-positive T cells in circulation
Time frame: 6 months
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: Yes
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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.
Department of Oncology, Xinqiao Hospital
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Retroviral vector-transduced autologous T cells to express CD22-specific CARs in people with Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Follicular Lymphoma, run by Xinqiao Hospital of Chongqing 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 15 inclusion and 13 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 10 Mar 2017. 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 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (time frame: 4 Weeks). 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 10 Mar 2017.