Diffuse Large B Cell LymphomaPhase 1NCT03999697
A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies
A Phase 1 study testing Autologous chimeric antigen receptor T cell transfusing agent targeting CD22 in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of CD22-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of recurrent or refractory CD22 positive B cell acute lymphoblastic leukemia (B-ALL) Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Primary Cutaneous Follicle Centre Lymphoma
- What is being tested?
- Autologous chimeric antigen receptor T cell transfusing agent targeting CD22
- 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
- 1 Dec 2018to 1 Dec 2020
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects with CD22+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD22-CAR-T cell therapy trials may be eligible if their CD22-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD22-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:
- Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD22+.
- Patients 3 years of age or older, and must have a life expectancy > 12 weeks.
- Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
- Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR CD22 cells.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
- Ability to give informed consent.
Who cannot join
- Patients with symptomatic central nervous system (CNS) involvement.
- Pregnant or nursing women may not participate.
- Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products.
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- The existence of unstable or active ulcers or gastrointestinal bleeding.
- Patients with a history of organ transplantation or are waiting for organ transplantation.
- Patients need anticoagulant therapy (such as warfarin or heparin).
- Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PersonGen·Anke cellular therapeutics Co., Ltd
Hefei, Anhui, 230088
Lin Yang, Ph.D
Lin Yang, Ph.D
About this study
Official title: Clinical Study of CD22 CAR T Cells in the Treatment of Patients With Relapsed or Refractory CD22 Positive B Cells With Acute Lymphoblastic Leukemia
Evaluation of the efficacy and safety of CD22-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of recurrent or refractory CD22 positive B cell acute lymphoblastic leukemia (B-ALL)
- Conditions
- Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Primary Cutaneous Follicle Centre Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Mantle Cell Lymphoma, Plasma Cell Neoplasm
- Being tested
- Autologous chimeric antigen receptor T cell transfusing agent targeting CD22
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Neoplasms, Plasma Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous chimeric antigen receptor T cell transfusing agent targeting CD22Drug
The enrolled patients will receive autologous-derived CD22-targeted CAR-T cells in 1 day with 100% of the total expected dosage after receiving lymphodepleting chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| CAR-CD22 Cell immunotherapy | Experimental | Enrolled patients will receive CAR-CD22 cell immunotherapy with a novel specific chimeric antigen receptor targeting CD22 antigen by infusion. Receives: Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22 |
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 CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03
Measured: 2 years
The effect after treatment
ORR within 24 weeks after infusion （CR+CRi）
Measured: 24 weeks
Secondary outcomes (1)
In vivo existence of Anti-CD22 CAR-T cells
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 posted27 Jun 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999697
- Sponsor's protocol ID
- PG-CART-22-I-001
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CD22 CAR T Cells in the Treatment of Patients With Relapsed or Refractory CD22 Positive B Cells With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03999697
- Acronym / sponsor ID
- PG-CART-22-I-001
- Conditions
- Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Primary Cutaneous Follicle Centre Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Mantle Cell Lymphoma, Plasma Cell Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 27 Jun 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.
Evaluation of the efficacy and safety of CD22-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of recurrent or refractory CD22 positive B cell acute lymphoblastic leukemia (B-ALL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-CD22 Cell immunotherapy | Experimental | Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22Enrolled patients will receive CAR-CD22 cell immunotherapy with a novel specific chimeric antigen receptor targeting CD22 antigen by infusion. |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects with CD22+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD22-CAR-T cell therapy trials may be eligible if their CD22-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD22-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:
- Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD22+.
- Patients 3 years of age or older, and must have a life expectancy > 12 weeks.
- Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
- Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR CD22 cells.
Key exclusion criteria (10 listed)
- Patients with symptomatic central nervous system (CNS) involvement.
- Pregnant or nursing women may not participate.
- Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
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 |
|---|---|---|
| Autologous chimeric antigen receptor T cell transfusing agent targeting CD22The enrolled patients will receive autologous-derived CD22-targeted CAR-T cells in 1 day with 100% of the total expected dosage after receiving lymphodepleting chemotherapy | Drug | CAR-CD22 Cell immunotherapy |
Primary outcome
Adverse Events That Are Related to Treatment
Time frame: 2 years
Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03
The effect after treatment
Time frame: 24 weeks
ORR within 24 weeks after infusion （CR+CRi）
1 secondary outcome
In vivo existence of Anti-CD22 CAR-T cells
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 27 Jun 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.
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 Autologous chimeric antigen receptor T cell transfusing agent targeting CD22 in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. 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 7 inclusion and 10 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 27 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 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?
Contact Lin Yang, Ph.D (86-0551-65728070, lin.yang@persongen.com.cn), 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). The study lists 2 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 27 Jun 2019.