CAREarly Phase 1NCT04700319
CAR-T CD19/CD20 for Patients With Advanced CD19/CD20+ B Cell Line Recurrent or Refractory Hematological Malignancies
A Early Phase 1 study testing CD19/CD20 CAR-T cell infusion in people with CAR, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a clinical study of CD19 / CD20 CAR-T cell infusion in the treatment of relapsed or refractory hematological malignancies in CD19 / CD20 positive B cell lines. The aim of this study was to evaluate the efficacy and safety of autologous chimeric antigen receptor T cell infusion targeting CD19/CD20 in the… Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- CAR
- What is being tested?
- CD19/CD20 CAR-T cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2019to 1 Jun 2021
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only subjects meeting all of the following conditions were included in the study:
- The subjects who voluntarily participated in the study and signed the written informed consent;
- The age at the time of signing the informed consent is 3-70 years old, regardless of gender or race;
- The patients with CD19 / CD20 positive hematological malignancies without other effective treatment options include those who are not suitable for allogeneic stem cell transplantation (SCT) due to the following reasons:Age; Concurrent diseases; Other contraindications, such as total body irradiation (TBI) contraindications (TBI is one of the important treatment measures before allogeneic stem cell transplantation in all patients); Lack of suitable donors;
- Expected survival > 12 weeks;
- Relapse after any stem cell transplantation (no matter what previous treatment plan); and;
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- Patients who relapsed after previous allogeneic SCT (myeloablative or non myeloablative) and met all other inclusion criteria:
- There was no active GVHD and no immunosuppression was required;
- Transplantation lasted more than 4 months;
- Serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl;
- Serum AST and alt ≤ 5 x upper limit of normal value (ULN);
- It is necessary to have indicators for disease detection or evaluation, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR;
- Cardiac function: left ventricular ejection fraction greater than or equal to 40%;
- ECoG physical condition (PS) ≤ 2;
- The pregnant test results of fertile female subjects within 48 hours before the infusion were negative and they were not in lactation period; all fertile female subjects took adequate contraceptive measures before entering the study and within 3 months after stopping the last infusion during the whole study period.
Who cannot join
- Pregnant or lactating female patients;
- Participate in another clinical trial within 4 weeks before the study, or intend to participate in another clinical trial during the whole study period;
- Uncontrolled active infection;
- The history of human immunodeficiency virus is known;
- Active hepatitis B or hepatitis C infection;
- The systemic steroid treatment is needed during cell infusion or cell collection, or there are some diseases that researchers think may need steroid treatment during blood collection or infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone for physiological replacement therapy in patients with adrenocortical insufficiency are also allowed;
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- There are grade 2-4 acute or systemic chronic GVHD;
- There is GVHD under treatment;
- Patients with cns3 disease progression or central nervous system parenchymal lesions that may increase central nervous system toxicity; patients with active central nervous system leukemia or lymphoma infiltration;
- Absolute neutrophil count < 750 / μ L or platelet count < 50000 / μ l caused by non primary diseases;
- When collecting cells, they received systemic chemotherapy 2 weeks ago or radiotherapy 3 weeks ago;
- Researchers believe that it is not suitable to participate in this clinical trial due to various reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
xingbing wang, doctor, +8613856007984, wangxingbing@ustc.edu.cn
About this study
This is a clinical study of CD19 / CD20 CAR-T cell infusion in the treatment of relapsed or refractory hematological malignancies in CD19 / CD20 positive B cell lines.
The aim of this study was to evaluate the efficacy and safety of autologous chimeric antigen receptor T cell infusion targeting CD19/CD20 in the treatment of relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.
Read the detailed description
CD19 and CD20 are two proteins expressed in normal B cells and various B cell-derived hematological malignancies, including non Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (all) and chronic lymphoblastic leukemia (CLL). CD19 and CD20 are restricted to the surface of B cells. They are not expressed in hematopoietic stem cells, nor in other tissue cells. They exist in all stages of B cell development and differentiation. They are not lost from the cell surface until B cells differentiate into plasma cells. Clinical studies have found that CD19 and CD20 are excellent targets for immunotherapy of B-cell malignancies.The purpose of this study was to observe the efficacy and safety of treatment for patients with relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.
- Conditions
- CAR
- Being tested
- CD19/CD20 CAR-T cell infusion
- Keywords
- B cell line, hematological malignancies
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/CD20 CAR-T cell infusionDrug
Also called Targeting CD19、CD20 autologous chimeric antigen receptor T cells#
CD19/CD20 CAR-T,Infusion,iv,0.2×10^6-5×10^6γδT /kg,once
| Study group | Role | What they receive |
|---|---|---|
| CD19/CD20 CAR-T cell infusion | Experimental | CD19/CD20 CAR-T cell infusion on relapsed or refractory hematological malignancies of CD19 / CD20+ B cell line Receives: Drug: CD19/CD20 CAR-T cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR 3
3-month objective response rate
Measured: three months after CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start19 Apr 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CARStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- Investigators
- Xingbing Wang, Principal investigator, No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700319
- Sponsor's protocol ID
- PA-CART-1920-I -001
- Status last verified
- Mar 2021
- First submitted
- 5 Jan 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T CD19/CD20 for Patients With Advanced CD19/CD20+ B Cell Line Recurrent or Refractory Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04700319
- Acronym / sponsor ID
- PA-CART-1920-I -001
- Conditions
- CAR
- Keywords
- B cell line, hematological malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 7 Jan 2021 (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 is a clinical study of CD19 / CD20 CAR-T cell infusion in the treatment of relapsed or refractory hematological malignancies in CD19 / CD20 positive B cell lines.
The aim of this study was to evaluate the efficacy and safety of autologous chimeric antigen receptor T cell infusion targeting CD19/CD20 in the treatment of relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.
Detailed description
CD19 and CD20 are two proteins expressed in normal B cells and various B cell-derived hematological malignancies, including non Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (all) and chronic lymphoblastic leukemia (CLL). CD19 and CD20 are restricted to the surface of B cells. They are not expressed in hematopoietic stem cells, nor in other tissue cells. They exist in all stages of B cell development and differentiation. They are not lost from the cell surface until B cells differentiate into plasma cells. Clinical studies have found that CD19 and CD20 are excellent targets for immunotherapy of B-cell malignancies.The purpose of this study was to observe the efficacy and safety of treatment for patients with relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19/CD20 CAR-T cell infusion | Experimental | Drug: CD19/CD20 CAR-T cell infusionCD19/CD20 CAR-T cell infusion on relapsed or refractory hematological malignancies of CD19 / CD20+ B cell line |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- The subjects who voluntarily participated in the study and signed the written informed consent;
- The age at the time of signing the informed consent is 3-70 years old, regardless of gender or race;
- The patients with CD19 / CD20 positive hematological malignancies without other effective treatment options include those who are not suitable for allogeneic stem cell transplantation (SCT) due to the following reasons:Age; Concurrent diseases; Other contraindications, such as total body irradiation (TBI) contraindications (TBI is one of the important treatment measures before allogeneic stem cell transplantation in all patients); Lack of suitable donors;
- Expected survival > 12 weeks;
- Relapse after any stem cell transplantation (no matter what previous treatment plan); and;
Key exclusion criteria (12 listed)
- Pregnant or lactating female patients;
- Participate in another clinical trial within 4 weeks before the study, or intend to participate in another clinical trial during the whole study period;
- Uncontrolled active infection;
- The history of human immunodeficiency virus is known;
- 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 |
|---|---|---|
| CD19/CD20 CAR-T cell infusionAlso: Targeting CD19、CD20 autologous chimeric antigen receptor T cells#CD19/CD20 CAR-T,Infusion,iv,0.2×10^6-5×10^6γδT /kg,once | Drug | CD19/CD20 CAR-T cell infusion |
Primary outcome
ORR 3
Time frame: three months after CAR-T cells infusion
3-month objective response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
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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.
Xingbing Wang principal investigator
No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD19/CD20 CAR-T cell infusion in people with CAR, 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 15 inclusion and 12 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 8 Mar 2021. 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?
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 Xingbing Wang (13856007984, wangxingbing@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR 3 (time frame: three months after CAR-T cells infusion). 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 8 Mar 2021.