CD7+ T-ALL/LBLPhase 1R/R T-ALL/LBLNCT07623681
Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children and Adolescents With Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
A Phase 1 study testing T cell injection targeting CD7 chimeric antigen receptor in people with CD7+ T-ALL/LBL, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- CD7+ T-ALL/LBL
- 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
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 30 Jul 2028
- Phase
- Phase 1
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (1) Aged from 3 to 18 years (inclusive), with no restriction on gender. (2) Expected survival time ≥ 3 months. (3) At screening, Karnofsky Performance Status score (for subjects aged ≥ 16 years) or Lansky Performance Score (for subjects aged < 16 years) > 60 points (see Appendix 4).
- Diagnosed with T-ALL or T-LBL (including ETP-ALL and ETP-LBL) by local laboratories based on the classification criteria of WHO Classification of Haematolymphoid Tumours, 5th Edition: Lymphoid Neoplasms, confirmed via MICM classification (morphology, immunology, cytogenetics and molecular genetics), and/or pathological and imaging examinations.
- For subjects diagnosed with T-LBL: bone marrow smear shows blasts between 5% (inclusive) and 20% (exclusive), or focal infiltration is observed on bone marrow biopsy indicating bone marrow involvement of T-LBL.
- Subjects with relapsed or refractory disease after failure of standard treatment or without available effective treatment options:
- ① Refractory disease: Failure to achieve remission after completion of at least 2 cycles of standard induction chemotherapy.
- ② Relapsed disease: New extramedullary lesions or bone marrow recurrence occurring in subjects who have achieved complete remission (CR).
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- Early relapse (< 12 months) after complete remission; Late relapse (≥ 12 months) after complete remission with no response to one cycle of standard induction chemotherapy.
- Definition of bone marrow recurrence: If the percentage of blasts/immature lymphocytes in bone marrow smear is ≥ 5% and < 20%, evidence of molecular recurrence is required. In the absence of molecular recurrence evidence, at least two consecutive test results (both ≥ 5%) are required.
- Failure to achieve remission after treatment with two or more lines of chemotherapy regimens*.
- Two or more episodes of relapse.
- Relapse after hematopoietic stem cell transplantation. * Remission criteria: CR and CRi for T-ALL; CR and PR for T-LBL. (6) At screening: ① Abnormal tumor cells are detected in bone marrow and/or peripheral blood by multi-color flow cytometry, regardless of the presence or absence of extramedullary lesions on imaging. Abnormal tumor cells in bone marrow must be CD7-positive; abnormal tumor cells in peripheral blood must be CD7-positive, CD4-negative and CD8-negative.
- No abnormal tumor cells are detected in bone marrow and/or peripheral blood by multi-color flow cytometry, and imaging shows only extramedullary lesions (e.g. lymphadenopathy). Immunohistochemistry of lesion specimens must confirm CD7 positivity with a CD7 positive rate ≥ 70%.
- For subjects with only extramedullary lesions: lesions shall be evaluable (by PET-CT) or measurable (by contrast-enhanced CT) per the 2014 Lugano Criteria for efficacy assessment specified in Appendix 5.
- Liver, renal, cardiac and pulmonary function shall meet the following criteria:
- ① Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN. If ALT/AST elevation is judged by the investigator to be caused by the underlying disease (e.g. liver infiltration or biliary obstruction), the upper limit may be extended to ≤ 5 × ULN. For subjects diagnosed with Gilbert's syndrome, total bilirubin ≤ 3.0 × ULN with direct bilirubin ≤ 1.5 × ULN.
- Creatinine ≤ 1.5 × ULN.
- Left ventricular ejection fraction (LVEF) ≥ 45%. ④ Oxygen saturation > 91%. (9) The subject and/or legal guardian fully understands this trial, has signed the informed consent form, and is willing and able to comply with scheduled visits, treatment regimens, laboratory tests and all other study requirements specified in the study schedule.
Who cannot join
- (1) Patients judged by the investigator to require long-term use of immunosuppressants at screening.
- Cerebrovascular accident or seizure occurring within 6 months prior to signing the informed consent form.
- Uncontrolled graft-versus-host disease (GvHD) or ongoing requirement for systemic treatment for GvHD.
- History of other malignancies (other than T-ALL/LBL) within 5 years prior to screening, except for cured carcinoma in situ.
- Subjects with positive hepatitis B surface antigen (HBsAg) and abnormal peripheral blood hepatitis B virus (HBV) DNA titer; positive hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA titer; positive hepatitis C virus (HCV) antibody coupled with positive peripheral blood HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; positive syphilis serology; positive Epstein-Barr virus (EBV) DNA.
- Severe cardiac diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] Class ≥ III), and severe arrhythmia.
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- Unstable systemic diseases as assessed by the investigator, including but not limited to severe hepatic, renal or metabolic diseases requiring medical treatment.
- Presence of chronic progressive neurological diseases. (9) Patients with unresolved acute toxicities from prior treatments. (10) Active or uncontrolled infections requiring systemic therapy (excluding mild genitourinary tract infections and upper respiratory tract infections).
- Female subjects of childbearing potential who plan to become pregnant within 2 years after cell infusion; male subjects whose partners plan to become pregnant within 2 years after cell infusion.
- Subjects who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
- Participation in another clinical trial within 1 month prior to screening (calculated from the last administration of unapproved investigational products).
- Evidence of central nervous system (CNS) involvement identified at screening.
- Any other conditions deemed ineligible for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
PersonGen Anke Cellular Therapeutice Co,Ltd.
Hefei, Anhui, 230088
Huimin Meng, Doctor, +86-180615580390, huimin.meng@persongen.com
About this study
This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient population.
Secondary objectives include evaluating the pharmacokinetics/pharmacodynamics, preliminarily assessing clinical efficacy, and evaluating the immunogenicity of the injection.
Read the detailed description
In the dose-escalation phase of this phase I trial, the conventional 3+3 design is adopted with three dose cohorts. The starting dose is 1×10^6 CAR-T cells/kg, followed by incremental doses of 2×10^6CAR-T cells/kg and 4×10^6CAR-T cells/kg. A total of 9 to 18 pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma will be enrolled.
In the first and second cohorts, subsequent participants may receive treatment after the prior subject completes a minimum 14-day safety observation period. For the third cohort, dosing of the next subject can proceed only after a 28-day safety monitoring period for the previous participant.
After the final subject in each cohort finishes the 28-day dose-limiting toxicity (DLT) assessment post single administration, enrollment for the next cohort can commence upon approval from the Safety Review Committee based on clinical safety data.
If one DLT occurs among 3 subjects in a cohort, 3 additional participants will be enrolled in the same cohort, bringing the total assessed subjects to 6. No further dose escalation will be conducted if one or more DLTs are observed in the supplementary subjects. Enrollment will then resume at the preceding lower dose level with another 3 subjects for DLT evaluation.
During the dose expansion phase of the phase I trial, the Safety Review Committee will review available safety, efficacy, pharmacokinetic and immunogenicity data to comprehensively determine the recommended phase II dose. At least 3 additional participants will be enrolled at this dose level. No dosing interval restriction or DLT assessment is required for expanded enrollment, so as to further confirm the preliminary efficacy and safety of the recommended phase II dose.
- Conditions
- CD7+ T-ALL/LBL
- 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
PA3-17 injection The subjects,who sign the informed consent forms and been screened by inclusion/exclusion criteria,will be assigned into 1.0*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.
| Study group | Role | What they receive |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental | PA3-17 injection The subjects,who sign the informed consent forms and been screened by inclusion/exclusion criteria,will be assigned into 1.0*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. 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.
MTD
Maximum tolerated dose
Measured: About 2 years
DLT
Dose limiting toxicity
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 posted3 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD7+ T-ALL/LBLStudies 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
- Model description
- PA3-17 injection
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiuli Ju, Doctor, Principal investigator, Qilu Hospital of Shandong UniversityXiaojun Xu, Doctor, Principal investigator, The Children's Hospital of Zhejiang University School of MedicineFen Zhou, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623681
- Sponsor's protocol ID
- PG-013
- Acronym
- R/R T-ALL/LBL
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children and Adolescents With Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT07623681
- Acronym / sponsor ID
- R/R T-ALL/LBL / PG-013
- Conditions
- CD7+ T-ALL/LBL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 3 Jun 2026 (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 trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient population.
Secondary objectives include evaluating the pharmacokinetics/pharmacodynamics, preliminarily assessing clinical efficacy, and evaluating the immunogenicity of the injection.
Detailed description
In the dose-escalation phase of this phase I trial, the conventional 3+3 design is adopted with three dose cohorts. The starting dose is 1×10^6 CAR-T cells/kg, followed by incremental doses of 2×10^6CAR-T cells/kg and 4×10^6CAR-T cells/kg. A total of 9 to 18 pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma will be enrolled.
In the first and second cohorts, subsequent participants may receive treatment after the prior subject completes a minimum 14-day safety observation period. For the third cohort, dosing of the next subject can proceed only after a 28-day safety monitoring period for the previous participant.
After the final subject in each cohort finishes the 28-day dose-limiting toxicity (DLT) assessment post single administration, enrollment for the next cohort can commence upon approval from the Safety Review Committee based on clinical safety data.
If one DLT occurs among 3 subjects in a cohort, 3 additional participants will be enrolled in the same cohort, bringing the total assessed subjects to 6. No further dose escalation will be conducted if one or more DLTs are observed in the supplementary subjects. Enrollment will then resume at the preceding lower dose level with another 3 subjects for DLT evaluation.
During the dose expansion phase of the phase I trial, the Safety Review Committee will review available safety, efficacy, pharmacokinetic and immunogenicity data to comprehensively determine the recommended phase II dose. At least 3 additional participants will be enrolled at this dose level. No dosing interval restriction or DLT assessment is required for expanded enrollment, so as to further confirm the preliminary efficacy and safety of the recommended phase II dose.
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 receptorPA3-17 injection The subjects,who sign the informed consent forms and been screened by inclusion/exclusion criteria,will be assigned into 1.0*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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- (1) Aged from 3 to 18 years (inclusive), with no restriction on gender. (2) Expected survival time ≥ 3 months. (3) At screening, Karnofsky Performance Status score (for subjects aged ≥ 16 years) or Lansky Performance Score (for subjects aged < 16 years) > 60 points (see Appendix 4).
- For subjects diagnosed with T-LBL: bone marrow smear shows blasts between 5% (inclusive) and 20% (exclusive), or focal infiltration is observed on bone marrow biopsy indicating bone marrow involvement of T-LBL.
- Subjects with relapsed or refractory disease after failure of standard treatment or without available effective treatment options:
- ① Refractory disease: Failure to achieve remission after completion of at least 2 cycles of standard induction chemotherapy.
- ② Relapsed disease: New extramedullary lesions or bone marrow recurrence occurring in subjects who have achieved complete remission (CR).
Key exclusion criteria (13 listed)
- (1) Patients judged by the investigator to require long-term use of immunosuppressants at screening.
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 receptorPA3-17 injection The subjects,who sign the informed consent forms and been screened by inclusion/exclusion criteria,will be assigned into 1.0*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. | Biological | T cell injection targeting CD7 chimeric antigen receptor |
Primary outcome
MTD
Time frame: About 2 years
Maximum tolerated dose
DLT
Time frame: About 2 years
Dose limiting toxicity
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 3 Jun 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.
Xiuli Ju, Doctor principal investigator
Qilu Hospital of Shandong University
Xiaojun Xu, Doctor principal investigator
The Children's Hospital of Zhejiang University School of Medicine
Fen Zhou, 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+ T-ALL/LBL, 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: opening soon, as of the sponsor's last update on 3 Jun 2026. 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?
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 Xiaofan Zhu, doctor (13752090418, Zhuxiaofan@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (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 3 Jun 2026.