Peripheral T Cell LymphomaEarly Phase 1NCT05979792
Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma
A Early Phase 1 study testing CAR-T Therapy in people with Peripheral T Cell Lymphoma, run by Zhao Weili at 8 sites in China.
Trial summary
Despite the use of monoclonal antibodies, checkpoint inhibitors, and bispecific T cell adapters (BiTE) Immunotherapies such as chimeric antigen receptor (CAR) T cells have completely changed the treatment methods of various cancers. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- CAR-T Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesChina
- Study dates
- 1 Sep 2023to 1 Dec 2025
- 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 18 to 79 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, including but not limited to: peripheral T Cell lymphoma, non-specific type (PTCL-NOS), anaplastic large cell lymphoma (ALCL), T helper cell lymphoma (FTCL), peripheral lymph nodes with follicular helper T cell phenotype T-cell lymphoma (TFH) and angioimmunoblastic T-cell lymphoma (AITL), Etc;
- Relapse or refractory peripheral T-cell lymphoma, which requires at least 2 systematic Sex therapy, is invalid or relapses.
- Histologically confirmed as CD7 positive.
- According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion (with the longest diameter of the intranodal lesion>1.5cm and the longest diameter of the extranodal lesion>1.0cm), and PET/CT should show metabolic activity.
- Blood routine neutrophil count ≥ 1.0 during screening × 109/L; 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 (if the patient does not meet the screening requirements but meets the screening period requirements for re examination, they can be selected).
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- The average fluorescence intensity (MFI) of donor specific antibodies (DSA) at HLA sites of HLA antibody negative or anti RD13-02 cell derived donors is less than 2000.
- Creatinine clearance rate>60ml/min (Cockcroft and Gault formula); For patients without liver invasion, 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; For patients with liver invasion, serum total bilirubin ≤ 3 times the upper limit of normal value, and serum ALT and AST ≤ 5 times the upper limit of normal value range.
- Echocardiography showed that 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.
- For patients undergoing reinfusion, in addition to meeting the relevant conditions for reinfusion in the Design of experiments, it is required that there is no DLT event or dose reduction after the first infusion.
- The first 6 subjects included at any dose level should be able to collect sufficient amounts of autologous hematopoietic stem cells for cryopreservation in advance; Subsequent subjects will be determined by the researcher whether to collect autologous hematopoietic stem cells for cryopreservation.
Who cannot join
- Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); Enteropathy associated T-cell lymphoma (EATL), monotypic epitheliophagocytic intestinal T-cell lymphoma (MEITL), hepatosplenic T-cell lymphoma (HSTCL), extranodal NK/T-cell lymphoma, nasal type (EENKTCL) and primary central nervous system lymphoma and other types of T-cell leukemia/lymphoma.
- Active central nervous system (CNS) invasion.
- If anti-tumor treatment has been received before infusion, it should be excluded if any of the following conditions are met:
- received small molecule Targeted therapy within 72 hours
- Received systemic chemotherapy within 2 weeks (excluding pre-treatment)
- Received radiation therapy within 4 weeks
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- When the time between the last monoclonal antibody infusion and those who have received monoclonal antibody treatment is less than 5 half-lives four weeks long or less (whichever is shorter)
- Individuals with a history of allergies to any component in cellular products.
- According to the New York Heart Association (NYHA) cardiac function grading standards, subjects with 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.
- Uncontrolled severe active infections (excluding simple urinary tract infections and bacterial pharyngitis).
- The subject has a history of other primary cancers, except for the following:
- Non Melanoma cured by excision, such as skin Basal-cell carcinoma;
- Carcinoma in situ of cervix, local prostate cancer, and ductal Carcinoma in situ with disease-free survival ≥ 2 years after adequate treatment;
- 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 Sex hormone treatment before screening and who were judged by the investigator to need long-term use of systemic Sex 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
8 sites in 1 country.
8 sites in 1 country
China8 sites
West China Hospital Sichuan University
Chengdu, Sichuan, 610000
Tin Niu, Doctor
Tin Niu, Doctor
The First Affiliated Hospital of USTC
Hefei, Anhui, 230000
Xiaoyu Zhu, Doctor
Xiaoyu Zhu, Doctor
The 920th Hospital of the Joint Service Support Force of the People's Liberation Army
Kunming, Yunan, 650000
Sanbin Wang, Doctor
Sanbin Wang, Doctor
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Weili Zhao, Doctor
The Affliliated Hospital of Northwest University
Xi’an, Shanxi, 710000
Xiequn Chen, Doctor
Xiequn Chen, Doctor
The First Affliliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Bing Xu, Doctor
Bing Xu, Doctor
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Keshu Zhou, Doctor
Keshu Zhou, Doctor
The First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Mingzhi Zhang, Doctor
Mingzhi Zhang
About this study
Despite the use of monoclonal antibodies, checkpoint inhibitors, and bispecific T cell adapters (BiTE) Immunotherapies such as chimeric antigen receptor (CAR) T cells have completely changed the treatment methods of various cancers.
However, only limited responses were observed in T cell diseases, In CD30 positive PTCL and CTCL patients. The use of BV in and pembroluzimab (Programmed cell death receptor 1) in the treatment of ENKTL.
Read more
Although some promising results have been observed for (PD-1) inhibitors, these positive results are limited to specific subtypes of T cell diseases.
CAR T Cell therapy in recurrent/refractory B-cell malignant tumors is very successful, the Food and Drug Administration (FDA) has approved two CAR T Cell therapy for the treatment of this type of disease. However, using this technology to treat T-cell malignancies has always been difficult, mainly due to the lack of tumor specific surface antigens in cancerous T cells.
Therefore, our center plans to conduct a phase I clinical study of CAR-T to explore the possibility of bringing more treatment options and benefits to PTCL patients.
Read the detailed description
Patients with recurrent/refractory PTCL were included using a single arm, open label, and single center approach.
Pre treatment plan:
Cyclophosphamide (CTX): 500mg/m2 × 3 days
Fludarabine: 30mg/m2 × 3 days
Note: Researchers can adjust the pre-treatment plan appropriately based on the patient's condition, such as CTX 300mg × Wait for 3 days.
CTX and Flu were infused on the 5th to 3rd day (D-5 to D-3) before administration. RD13-02 can only be injected after 48 hours of pre-treatment.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- CAR-T Therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T TherapyDrug
CAR-T cell infusion
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Therapy | Experimental | Not described Receives: Drug: CAR-T Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
DLT
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhao Weili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979792
- Sponsor's protocol ID
- BHCT-RD13-02P
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05979792
- Acronym / sponsor ID
- BHCT-RD13-02P
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Zhao WeiliUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Aug 2023 (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.
Despite the use of monoclonal antibodies, checkpoint inhibitors, and bispecific T cell adapters (BiTE) Immunotherapies such as chimeric antigen receptor (CAR) T cells have completely changed the treatment methods of various cancers.
However, only limited responses were observed in T cell diseases, In CD30 positive PTCL and CTCL patients. The use of BV in and pembroluzimab (Programmed cell death receptor 1) in the treatment of ENKTL.
Although some promising results have been observed for (PD-1) inhibitors, these positive results are limited to specific subtypes of T cell diseases.
CAR T Cell therapy in recurrent/refractory B-cell malignant tumors is very successful, the Food and Drug Administration (FDA) has approved two CAR T Cell therapy for the treatment of this type of disease. However, using this technology to treat T-cell malignancies has always been difficult, mainly due to the lack of tumor specific surface antigens in cancerous T cells.
Therefore, our center plans to conduct a phase I clinical study of CAR-T to explore the possibility of bringing more treatment options and benefits to PTCL patients.
Detailed description
Patients with recurrent/refractory PTCL were included using a single arm, open label, and single center approach.
Pre treatment plan:
Cyclophosphamide (CTX): 500mg/m2 × 3 days
Fludarabine: 30mg/m2 × 3 days
Note: Researchers can adjust the pre-treatment plan appropriately based on the patient's condition, such as CTX 300mg × Wait for 3 days.
CTX and Flu were infused on the 5th to 3rd day (D-5 to D-3) before administration. RD13-02 can only be injected after 48 hours of pre-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T Therapy | Experimental | Drug: CAR-T Therapy |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 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, including but not limited to: peripheral T Cell lymphoma, non-specific type (PTCL-NOS), anaplastic large cell lymphoma (ALCL), T helper cell lymphoma (FTCL), peripheral lymph nodes with follicular helper T cell phenotype T-cell lymphoma (TFH) and angioimmunoblastic T-cell lymphoma (AITL), Etc;
- Relapse or refractory peripheral T-cell lymphoma, which requires at least 2 systematic Sex therapy, is invalid or relapses.
- Histologically confirmed as CD7 positive.
- According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion (with the longest diameter of the intranodal lesion>1.5cm and the longest diameter of the extranodal lesion>1.0cm), and PET/CT should show metabolic activity.
Key exclusion criteria (25 listed)
- Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); Enteropathy associated T-cell lymphoma (EATL), monotypic epitheliophagocytic intestinal T-cell lymphoma (MEITL), hepatosplenic T-cell lymphoma (HSTCL), extranodal NK/T-cell lymphoma, nasal type (EENKTCL) and primary central nervous system lymphoma and other types of T-cell leukemia/lymphoma.
- Active central nervous system (CNS) invasion.
- If anti-tumor treatment has been received before infusion, it should be excluded if any of the following conditions are met:
- Individuals with a history of allergies to any component in cellular products.
- According to the New York Heart Association (NYHA) cardiac function grading standards, subjects with cardiac dysfunction classified as Class III or IV.
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-T TherapyCAR-T cell infusion | Drug | CAR-T Therapy |
Primary outcome
Dose-limiting toxicity
Time frame: Up to 2 years
DLT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- 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. This study is not recruiting at the moment.
8 sites 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 CAR-T Therapy in people with Peripheral T Cell Lymphoma, run by Zhao Weili at 8 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 14 inclusion and 25 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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 Weili Zhao, Doctor (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Up to 2 years). 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 21 Aug 2023.