CD7 Positive R/R PTCLPhase 1S101PNCT07143929
To Observe the CD7-targeted CAR-T Therapy in the Treatment of r/r PTCL
A Phase 1 study testing CAR-T in people with CD7 Positive R/R PTCL, run by Peking University People's Hospital at 1 site in China.
Trial summary
To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CD7 Positive R/R PTCL
- What is being tested?
- CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2025to 31 Dec 2027
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and<80 years old；
- According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell lymphoma；
- Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the past；
- Histologically confirmed as CD7 positive；
- According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic activity.
- Blood routine neutrophil count ≥ 1.0×109/L during screening; For individuals without bone marrow invasion, platelet count ≥ 75×109/L, Hb≥80g/L; For individuals with bone marrow invasion, platelet count ≥50×109/L, Hb≥60g/L；
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- Creatinine clearance rate>60ml/min (Cockcroft and Gault formula); serum total bilirubin≤1.5 times the upper limit of normal value, and serum ALT and AST ≤ 3 times the upper limit of normal value range;
- left ventricular Ejection fraction (LVEF) ≥ 50%.
- Estimated survival time of over 3 months.
- ECOG: 0-1.
- Subjects or their Legal guardian voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); T-lymphoblastic leukemia/lymphoma（T-ALL/LBL）；
- Primary central nervous system cell lymphoma, or with active central nervous system invasion；
- If anti-tumor treatment has been received before infusion, and drugs have not been completely eliminated must be excluded;
- Individuals with a history of allergies to any component in cellular products.
- Cardiac function:cardiac dysfunction classified as Class III or IV；Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart disease clinically within 12 months of enrollment；The electrocardiogram indicates that the QT interval is significantly prolonged, and the patient has serious heart disease such as serious arrhythmia in the past.
- Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
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- Uncontrolled severe active infections.
- The subject has a history of other primary cancers, except for the following.
- Subjects with autoimmune diseases requiring treatment or subjects requiring Immunosuppressive drug treatment.
- Individuals with graft versus host disease (GvHD) and/or requiring immunosuppressive therapy.
- Live vaccination within 4 weeks prior to screening.
- The subject has a history of alcoholism, drug abuse, or mental illness.
- Individuals with EBV DNA copy numbers greater than the upper limit of normal or positive for EBER; CMV copies greater than the upper limit of normal values; HBV or HCV DNA copy number>the upper limit of normal value, and active syphilis or AIDS and other virus infected persons.
- Subjects who were receiving systemic hormone treatment before screening and who were judged by the investigator to need long-term use of systemic hormone during treatment (except for inhalation or local use).
- Individuals who have participated in other clinical trials within the first 4 weeks of screening.
- Pregnant and lactating women and subjects with Fertility who cannot take effective contraceptive measures (both men and women).
- Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Dose-escalation Early-phase Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL.
Read the detailed description
In this study, anti CD7 CAR-T cell therapy will be explored for patients with relapsed/refractory PTCL. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of CAR-T cells in r/r PTCL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。
- Conditions
- CD7 Positive R/R PTCL
- Being tested
- CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TDrug
autologous CD7-targeted CAR-T cells, single injection
| Study group | Role | What they receive |
|---|---|---|
| anti CD7 CAR-T cells | Experimental | eligible patients will be treated with CD7-targeted CAR-T cells Receives: Drug: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety: Dose-limiting toxicity
Observe the incidence rate of DLT events within 28 days after cell infusion
Measured: at least 28 days after the CAR-T cells infusion
Secondary outcomes (1)
Efficacy of the anti CD7 CAR-T cells to R/R PTCL
Remission rate, remission rate includes complete remission(CR)、partial remission(PR)
Measured: at least 1 year after the 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 posted27 Aug 2025
- Study start18 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 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 R/R PTCLStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 3+3 dose escalation design
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143929
- Sponsor's protocol ID
- Anti CD7 CAR-T for r/r PTCL
- Acronym
- S101P
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Early-phase Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT07143929
- Acronym / sponsor ID
- S101P / Anti CD7 CAR-T for r/r PTCL
- Conditions
- CD7 Positive R/R PTCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Aug 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.
To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL.
Detailed description
In this study, anti CD7 CAR-T cell therapy will be explored for patients with relapsed/refractory PTCL. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of CAR-T cells in r/r PTCL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose escalation design
| Arm | Type | Receives |
|---|---|---|
| anti CD7 CAR-T cells | Experimental | Drug: CAR-Teligible patients will be treated with CD7-targeted CAR-T cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old and<80 years old；
- According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell lymphoma；
- Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the past；
- Histologically confirmed as CD7 positive；
- According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic activity.
Key exclusion criteria (17 listed)
- Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); T-lymphoblastic leukemia/lymphoma（T-ALL/LBL）；
- Primary central nervous system cell lymphoma, or with active central nervous system invasion；
- If anti-tumor treatment has been received before infusion, and drugs have not been completely eliminated must be excluded;
- Individuals with a history of allergies to any component in cellular products.
- Cardiac function:cardiac dysfunction classified as Class III or IV；Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart disease clinically within 12 months of enrollment；The electrocardiogram indicates that the QT interval is significantly prolonged, and the patient has serious heart disease such as serious arrhythmia in the past.
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 |
|---|---|---|
| CAR-Tautologous CD7-targeted CAR-T cells, single injection | Drug | anti CD7 CAR-T cells |
Primary outcome
safety: Dose-limiting toxicity
Time frame: at least 28 days after the CAR-T cells infusion
Observe the incidence rate of DLT events within 28 days after cell infusion
1 secondary outcome
Efficacy of the anti CD7 CAR-T cells to R/R PTCL
Time frame: at least 1 year after the CAR-T cells infusion
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 27 Aug 2025.
- Individual participant dataSharing planned: Undecided
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.
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 CAR-T in people with CD7 Positive R/R PTCL, run by Peking University People's Hospital 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 11 inclusion and 17 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 27 Aug 2025. 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 Xiaodong Mo, phd (8610-88326002, mxd453@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety: Dose-limiting toxicity (time frame: at least 28 days after the 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 27 Aug 2025.