CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/LymphomaPhase 2NCT07188610
PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
A Phase 2 study testing T cell injection targeting CD7 chimeric antigen receptor in people with CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 16 sites in China.
Trial summary
Translation: This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma
- 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
- 100 participants
- Where
- 16 sitesChina
- Study dates
- 25 Sep 2025to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age and Gender: ≥18 years old (inclusive), regardless of gender.
- Survival Expectancy: ≥3 months.
- Performance Status: ECOG score 0-1.
- Diagnosis: Confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the WHO fifth edition of the "Classification of Hematopoietic and Lymphoid Tumors," including early T-cell precursor (ETP).
- Recurrent or Refractory Disease: Subjects with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL).
- Screening: Abnormal cells CD7 expression positive.
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- Lesion Assessment: If the subject has only extramedullary lesions, they must have evaluable lesions.
- Meet the requirements of liver, kidney, heart, and lung functions.
- No Severe Mental Disorders.
- Informed Consent: Ability to understand the trial and signed informed consent form.
Who cannot join
- Known to have active or uncontrolled autoimmune diseases;
- Presence of GvHD;
- History of malignant tumors other than T-ALL/LBL within the past 5 years, except for adequately treated cervical intraepithelial neoplasia, basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ of the breast after radical surgery;
- Positive test results for hepatitis B, hepatitis C, syphilis, etc.;
- Severe heart disease;
- Unstable systemic diseases as judged by the investigator;
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- Presence of active infection or uncontrollable infection requiring systemic treatment;
- Pregnant or breastfeeding women, and female subjects planning to conceive within 2 years after cell infusion, or male subjects whose partners plan to conceive within 2 years after cell infusion;
- Subjects who have received CAR-T therapy or other gene-modified cell therapy before screening;
- Participation in other clinical studies within 1 month before screening (end date of the last application of unapproved innovative drugs);
- Evidence of central nervous system involvement at the time of subject screening;
- Situations judged by the investigator as not suitable for cell preparation;
- Other circumstances deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Meng Lv, MD, +86-15313960305, drlvmeng@163.com
Xiaojun Huang, MD
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Hongmei Jing, MD, +86-13661112910, bysyjhm@sina.com
Hongmei Jing, MD
- Recruiting
West China Hospital, Sichuan University (WCHSU)
Chengdu, Sichuan, 610000
Ting Niu, MD, +86-18980601242, tingniu@sina.com
Ting Niu, MD
- Recruiting
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, 510000
Qingqing Cai, MD, +86-13798101121, caiqq@sysucc.org.cn
- Not yet recruiting
Facility Name: Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Peilong Lai, Doctor, 13570931198, lai_peilong@163.com
Peilong Lai, Doctor
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jie Jin, MD, jiej0503@163.com
Jie Jin, MD
- Not yet recruiting
The First Hospital of Harbin
Harbin, Heilongjiang, 150000
Tiejun Gong, MD, +86-13836027737, gongtiejun567@163.com
Tiejun Gong, MD
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230000
Xingbing Wang, MD, +86-18056075256, wangxingbing@ustc.edu.cn
Xingbing Wang, MD
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
Lei Fan, MD, +86-13813976136, fanclinicaltrials@126.com
Lei Fan, MD
- Recruiting
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, 200000
Aibin Liang, MD, +86-18601670600, lab7182@tongji.edu.cn
Aibin Liang, MD
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Yang Xu, MD, +86-13732628683, xuyang1020@126.com
Yang Xu, MD
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
Dehui Zou, MD, +86-13602100955, zoudehui@ihcams.ac.cn
Dehui Zou, MD
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Heng Mei, MD, +86-13886160811, hmei@hust.edu.cn
Heng Mei, MD
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Wei Sang, MD, +86-13645207648, 13645207648@126.com
Wei Sang, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Keshu Zhou, MD, +86-13674902391, dr_zkshu23810@163.com
Keshu Zhou, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, MD, +86-13838565629, mingzhi_zhang@126.com
Mingzhi Zhang, MD
About this study
Official title: PA3-17 Injection for the Treatment of Subjects With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma: A Single-Arm, Open-Label Phase II Clinical Trial
Translation:
This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Following lymphodepletion pretreatment, a single infusion of PA3-17 injection will be administered. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations. In addition to the baseline period, the treatment phase will involve efficacy assessments at 4 weeks, 2 months, 3 months, and every 3 months thereafter, up to 24 months post-cell infusion. Tumor assessments will continue until disease progression (PD), initiation of new antitumor treatment, death, unacceptable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurs first.
- 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
After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells, followed by lymphodepletion pretreatment and a single infusion of PA3-17 injection.
| 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.
Efficacy
Three-month Objective Response Rate (ORR): Proportion of Composite Complete Response Rate (CRc: CR, CRh, CRi, MLFS) and PR
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start25 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (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 T Lymphoblastic Leukemia/LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188610
- Sponsor's protocol ID
- PG-002
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PA3-17 Injection for the Treatment of Subjects With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma: A Single-Arm, Open-Label Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07188610
- Acronym / sponsor ID
- PG-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 Sep 2025 (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.
Translation:
This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Following lymphodepletion pretreatment, a single infusion of PA3-17 injection will be administered. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations. In addition to the baseline period, the treatment phase will involve efficacy assessments at 4 weeks, 2 months, 3 months, and every 3 months thereafter, up to 24 months post-cell infusion. Tumor assessments will continue until disease progression (PD), initiation of new antitumor treatment, death, unacceptable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age and Gender: ≥18 years old (inclusive), regardless of gender.
- Survival Expectancy: ≥3 months.
- Performance Status: ECOG score 0-1.
- Diagnosis: Confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the WHO fifth edition of the "Classification of Hematopoietic and Lymphoid Tumors," including early T-cell precursor (ETP).
- Recurrent or Refractory Disease: Subjects with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL).
Key exclusion criteria (13 listed)
- Known to have active or uncontrolled autoimmune diseases;
- Presence of GvHD;
- History of malignant tumors other than T-ALL/LBL within the past 5 years, except for adequately treated cervical intraepithelial neoplasia, basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ of the breast after radical surgery;
- Positive test results for hepatitis B, hepatitis C, syphilis, etc.;
- Severe heart 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 |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptorAfter signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells, followed by lymphodepletion pretreatment and a single infusion of PA3-17 injection. | Biological | T cell injection targeting CD7 chimeric antigen receptor |
Primary outcome
Efficacy
Time frame: Three months
Three-month Objective Response Rate (ORR): Proportion of Composite Complete Response Rate (CRc: CR, CRh, CRi, MLFS) and PR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T cell injection targeting CD7 chimeric antigen receptor in people with CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 16 sites 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 10 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Huang, MD (+86-13701389625, xjhrm@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Three months). 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 6 Jul 2026.