CD7-positive Relapsed/Refractory Lymphoid Hematologic MalignanciesPhase 1NCT05170568
PA3-17 Injection Treatment of Adult Patients With CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
A Phase 1 study testing T cell injection targeting CD7 chimeric antigen receptor in people with CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I, open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
- What is being tested?
- T cell injection targeting CD7 chimeric antigen receptor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Dec 2024
- 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
- Aged 18 to 70 years old (inclusive), male or female;
- Expected survival time ≥ 3 months;
- ECOG performance status of 0-1;
- Malignant lymphoma diagnosed according to WHO2016 criteria: priority will be given to T-cell acute lymphoblastic leukemia/lymphoma (including early pre-T-cell lymphoblastic leukemia);
- Subjects with recurrent/refractory T-cell acute lymphoblastic leukemia/lymphoma (including early pre-T-cell lymphoblastic leukemia) who have failed standard treatment or lack effective treatment and meet any of the following criteria:
- No remission after at least two courses of standard induction chemotherapy;
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- Early relapse (<12 months) after complete remission; Or complete remission followed by late relapse (≥12 months) without remission after a course of standard induction chemotherapy;
- Patients who did not achieve remission after two or more lines of chemotherapy;
- Recurrence after hematopoietic stem cell transplantation.
- Lymphoid hematologic malignancies diagnosed as CD7 positive by flow cytometry and/or CD7 positive by histopathological immunohistochemistry at screening, with the positive rate of tumor ≥ 30%;
- For CD7-positive lymphoid hematologic malignancies involving bone marrow and/or peripheral blood, patients with CD4/CD8 double-negative surface immunophenotype of tumor cells as determined by flow cytometry;
- Liver, kidney and cardiopulmonary function shall meet the following requirements:
- Creatinine ≤ 1.5 ULN;
- Left ventricular ejection fraction ≥ 45%;
- Oxygen saturation > 91%;
- Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltration or bile duct obstruction) as judged by the investigator, the indicators can be relaxed to ≤ 5 × ULN;
- Patients who can understand the trial and have signed informed consents.
Who cannot join
- Subjects who need to use immunosuppressants;
- Subjects with malignant tumors other than T-cell hematological malignancies within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical mastectomy;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA test; positive for syphilis test;
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract infection);
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- Pregnant or lactating women, and female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after cell infusion;
- Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
- Subjects who are receiving systemic steroid therapy within 7 days prior to screening or need long-term use of systemic steroid therapy during treatment as judged by the investigator (except for inhalation or topical use);
- Subjects who have participated in other clinical studies within 3 months prior to screening;
- Subjects who have evidence of central nervous system invasion at screening;
- Conditions not eligible for cell preparation as judged by the investigator;
- Other conditions considered unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, 230088
Huimin Meng, Doctor, +86-18015580390, huimin.meng@persongen.com.cn
About this study
Official title: A Phase I Open-label, Dose-escalation Trial of PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
This is a Phase I, open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies. The secondary objectives are as follows: to evaluate the proliferation and in vivo persistence of CD7-targeted chimeric antigen receptor T (CAR-T) cells after injection of PA3-17; to evaluate the proportion of CD7-positive cells in peripheral blood after injection of PA3-17; to preliminarily evaluate the efficacy of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies; to evaluate the immunogenicity of PA3-17 injection; and to explore the applicable dose in Phase II trial.
Read the detailed description
Approximately 5 sites are planned to be selected for the clinical trial. The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 0.5 × 10^6, 2.0 × 10^6 and 4.0 × 10^6 CAR-T/kg groups in order of sequence. And the subjects will be administered once. Dose escalation will follow 3 + 3 design and 3-6 subjects in each group will complete a single dose. Within the same dose group, the next subject will be administered after the previous subject has completed at least 14 days of safety observation. After the last subject in each dose group has completed the dose-limiting toxicity (DLT) assessment window of 28 days after single dose, the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee (SRC) agrees to enter the next dose group based on clinical safety data assessment.
When DLT occurs in 1 of 3 subjects in a dose group, 3 additional subjects in the same dose group will be required (up to 6 subjects in the dose group have completed DLT assessment): if no DLT occurs in the additional 3 subjects, dose escalation will continue; if 1 of the 3 additional subjects experiences one DLT, dose escalation will be discontinued; if more than 1 of the 3 additional subjects experiences DLTs, dose escalation will be discontinued, and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment. After the end of escalation for the maximum dose group, if no MTD is observed, the highest dose level is defined as the MTD.
- Being tested
- T cell injection targeting CD7 chimeric antigen receptor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T cell injection targeting CD7 chimeric antigen receptorBiological
Also called PA3-17 injection
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 0.5 × 106, 2.0 × 106 and 4.0 × 106 CAR-T/kg groups in order of sequence. And the subjects will be administered once.
| Study group | Role | What they receive |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental | Not described Receives: Biological: T cell injection targeting CD7 chimeric antigen receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose limiting toxicity
Measured: About 2 years
MTD
Maximum tolerated dose
Measured: About 2 years
Secondary outcomes (13)
Assessment of the safety after CD7-targeted chimeric antigen receptor T cells infusion (Safety)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: About 2 years
Assessment of pharmacokinetic (about Cmax)
Assessment of the highest concentration (Cmax) of CD7-targeted chimeric antigen receptor T cells amplified in peripheral blood after administration.
Measured: 28 days
Assessment of pharmacokinetic (about Tmax)
Assessment of the time to reach the highest concentration (Tmax) of CD7-targeted chimeric antigen receptor T cells in peripheral blood after administration.
Measured: 28 days
Assessment of pharmacokinetic (about AUC0-28d)
Assessment of the area under the curve AUC0-28d after administration.
Measured: 28 days
Assessment of pharmacokinetic (about Cmax)
Assessment of the highest concentration (Cmax) of CD7-targeted chimeric antigen receptor T cells amplified in peripheral blood after administration.
Measured: 90 days
Assessment of pharmacokinetic (about Tmax)
Assessment of the time to reach the highest concentration (Tmax) of CD7-targeted chimeric antigen receptor T cells in peripheral blood after administration.
Measured: 90 days
Assessment of pharmacokinetic (about AUC0-90d)
Assessment of the area under the curve AUC0-90d after administration.
Measured: 90 days
PD endpoints
The proportion and absolute value of CD7-positive cells in peripheral blood at each time point; concentration levels of CAR-T-related serum cytokines such as CRP and IL-6;
Measured: About 2 years
To Evaluate Anti-tumour Activity (Overall Survival)
Defined as the time from start of CD7 CAR-T cell therapy to death (due to any cause);
Measured: About 2 year
To Evaluate Anti-tumour Activity (Progression Free Survival)
Defined as the time from the start of CD7 CAR-T cell therapy to the first disease progression or recurrence or death from any cause.
Measured: About 2 year
To Evaluate Anti-tumour Activity (overall response rate)
Rate of participants who with lymphoma aquire complete response (CR) or partial response (PR) or those who with leukemia CR or CR with incomplete hematologic recovery (CRi).
Measured: About 3 months
Immunogenicity endpoints
Positive rate of human anti-CAR antibody at each time point.
Measured: About 2 years
To Evaluate Anti-tumour Activity (duration of response)
Defined as the time from the first tumor assessment of CR or PR (lymphoma), CR or CRi (leukemia) to the first assessment of disease recurrence or progression or death due to any cause.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD7-positive Relapsed/Refractory Lymphoid Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by PersonGen BioTherapeutics (Suzhou) Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- PA3-17 injection
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Mingzhi Zhang, Doctor, Principal investigator, The First Affiliated Hospital of Zhengzhou UniversityXiaojun Huang, Doctor, Principal investigator, Peking University People's HospitalHeng Mei, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDehui Zou, Doctor, Principal investigator, Chinese Academy of Medical SciencesHe Huang, Doctor, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170568
- Sponsor's protocol ID
- PG-CART-07-001 (1)
- Status last verified
- Oct 2022
- First submitted
- 24 Dec 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Dose-escalation Trial of PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05170568
- Acronym / sponsor ID
- PG-CART-07-001 (1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 28 Dec 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 Phase I, open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies. The secondary objectives are as follows: to evaluate the proliferation and in vivo persistence of CD7-targeted chimeric antigen receptor T (CAR-T) cells after injection of PA3-17; to evaluate the proportion of CD7-positive cells in peripheral blood after injection of PA3-17; to preliminarily evaluate the efficacy of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies; to evaluate the immunogenicity of PA3-17 injection; and to explore the applicable dose in Phase II trial.
Detailed description
Approximately 5 sites are planned to be selected for the clinical trial. The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 0.5 × 10^6, 2.0 × 10^6 and 4.0 × 10^6 CAR-T/kg groups in order of sequence. And the subjects will be administered once. Dose escalation will follow 3 + 3 design and 3-6 subjects in each group will complete a single dose. Within the same dose group, the next subject will be administered after the previous subject has completed at least 14 days of safety observation. After the last subject in each dose group has completed the dose-limiting toxicity (DLT) assessment window of 28 days after single dose, the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee (SRC) agrees to enter the next dose group based on clinical safety data assessment.
When DLT occurs in 1 of 3 subjects in a dose group, 3 additional subjects in the same dose group will be required (up to 6 subjects in the dose group have completed DLT assessment): if no DLT occurs in the additional 3 subjects, dose escalation will continue; if 1 of the 3 additional subjects experiences one DLT, dose escalation will be discontinued; if more than 1 of the 3 additional subjects experiences DLTs, dose escalation will be discontinued, and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment. After the end of escalation for the maximum dose group, if no MTD is observed, the highest dose level is defined as the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PA3-17 injection
| Arm | Type | Receives |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental | Biological: T cell injection targeting CD7 chimeric antigen receptor |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 18 to 70 years old (inclusive), male or female;
- Expected survival time ≥ 3 months;
- ECOG performance status of 0-1;
- Malignant lymphoma diagnosed according to WHO2016 criteria: priority will be given to T-cell acute lymphoblastic leukemia/lymphoma (including early pre-T-cell lymphoblastic leukemia);
- Subjects with recurrent/refractory T-cell acute lymphoblastic leukemia/lymphoma (including early pre-T-cell lymphoblastic leukemia) who have failed standard treatment or lack effective treatment and meet any of the following criteria:
Key exclusion criteria (13 listed)
- Subjects who need to use immunosuppressants;
- Subjects with malignant tumors other than T-cell hematological malignancies within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical mastectomy;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA test; positive for syphilis test;
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
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 |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptorAlso: PA3-17 injectionThe subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 0.5 × 106, 2.0 × 106 and 4.0 × 106 CAR-T/kg groups in order of sequence. And the subjects will be administered once. | Biological | T cell injection targeting CD7 chimeric antigen receptor |
Primary outcome
DLT
Time frame: About 2 years
Dose limiting toxicity
MTD
Time frame: About 2 years
Maximum tolerated dose
13 secondary outcomes
Assessment of the safety after CD7-targeted chimeric antigen receptor T cells infusion (Safety)
Time frame: About 2 years
Assessment of pharmacokinetic (about Cmax)
Time frame: 28 days
Assessment of pharmacokinetic (about Tmax)
Time frame: 28 days
Assessment of pharmacokinetic (about AUC0-28d)
Time frame: 28 days
Assessment of pharmacokinetic (about Cmax)
Time frame: 90 days
Assessment of pharmacokinetic (about Tmax)
Time frame: 90 days
Assessment of pharmacokinetic (about AUC0-90d)
Time frame: 90 days
PD endpoints
Time frame: About 2 years
To Evaluate Anti-tumour Activity (Overall Survival)
Time frame: About 2 year
To Evaluate Anti-tumour Activity (Progression Free Survival)
Time frame: About 2 year
To Evaluate Anti-tumour Activity (overall response rate)
Time frame: About 3 months
Immunogenicity endpoints
Time frame: About 2 years
To Evaluate Anti-tumour Activity (duration of response)
Time frame: About 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- 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.
Mingzhi Zhang, Doctor principal investigator
The First Affiliated Hospital of Zhengzhou University
Xiaojun Huang, Doctor principal investigator
Peking University People's Hospital
Heng Mei, Doctor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 T cell injection targeting CD7 chimeric antigen receptor in people with CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies, 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 17 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 1 Nov 2022. 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 Mingzhi Zhang, Doctor (037166295562, mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: About 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 1 Nov 2022.