Lymphoma, T-CellNCT04928105
Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma
A study testing Senl-T7 in people with Lymphoma, T-Cell, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Lymphoma, T-Cell
- What is being tested?
- Senl-T7
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2021to 31 Mar 2023
- Phase
- Interventional
- 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Diagnosed as relapsed or refractory lymphoma; 2. Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry); 3. The expected survival period is greater than 12 weeks; 4. KPS or Lansky score ≥60; 11 5. Age 2-70 years old; 6. HGB≥70g/L (can be transfused); 7. Indoor blood oxygen saturation> 90%; 8. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value; 9. The subject or guardian understands and signs the informed consent form;
Who cannot join
- 1. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF<30% or LVEF< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment); 2. There is active GVHD; 3. Have a history of severe pulmonary dysfunction diseases; 4. Merge other malignant tumors in advanced stage; 5. Combined with severe infection or persistent infection and cannot be effectively controlled; 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] test positive); 8. Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection; 9. There is a history of severe allergies to biological products (including antibiotics); 10. Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6; 11. There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.; 12. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 13. Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei yanda Ludaopei Hospital
Yanda, Hebei
Peihua MD Lu, PhD, 008618611636172, peihua_lu@126.com
About this study
Official title: Clinical Study of Senl-T7 CAR-T Cells in the Treatment of Relapsed or Refractory CD7+ Lymphoma
This study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.
Read the detailed description
Main research purposes:
To evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma
Secondary research purpose:
To investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.
- Conditions
- Lymphoma, T-Cell
- Being tested
- Senl-T7
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senl-T7Biological
Patients will be treated with CD7 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| CD7 CAR-T | Experimental | Not described Receives: Biological: Senl-T7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CD7
Measured: First 1 month post CAR-T cells infusion
Remission Rate
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Measured: 3 months post CAR-T cells infusion
duration of response (DOR)
duration of response (DOR)
Measured: 24 months post CAR-T cells infusion
progression-free survival (PFS)
progression-free survival (PFS) time
Measured: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
Measured: 3 months post CAR-T cells infusion
CAR-T proliferation
percentage of CD7 CAR- T cells measured by flow cytometry method
Measured: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Measured: First 1 month post 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 posted16 Jun 2021
- Study start27 Jan 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-CellStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peihua MD Lu, PhD, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928105
- Sponsor's protocol ID
- Senl-T7 CART for CD7+ lymphoma
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Senl-T7 CAR-T Cells in the Treatment of Relapsed or Refractory CD7+ Lymphoma
- ClinicalTrials.gov ID
- NCT04928105
- Acronym / sponsor ID
- Senl-T7 CART for CD7+ lymphoma
- Conditions
- Lymphoma, T-Cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 16 Jun 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 study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.
Detailed description
Main research purposes:
To evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma
Secondary research purpose:
To investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD7 CAR-T | Experimental | Biological: Senl-T7 |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Diagnosed as relapsed or refractory lymphoma; 2. Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry); 3. The expected survival period is greater than 12 weeks; 4. KPS or Lansky score ≥60; 11 5. Age 2-70 years old; 6. HGB≥70g/L (can be transfused); 7. Indoor blood oxygen saturation> 90%; 8. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value; 9. The subject or guardian understands and signs the informed consent form;
Key exclusion criteria (1 listed)
- 1. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF<30% or LVEF< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment); 2. There is active GVHD; 3. Have a history of severe pulmonary dysfunction diseases; 4. Merge other malignant tumors in advanced stage; 5. Combined with severe infection or persistent infection and cannot be effectively controlled; 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] test positive); 8. Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection; 9. There is a history of severe allergies to biological products (including antibiotics); 10. Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6; 11. There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.; 12. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 13. Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.
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 |
|---|---|---|
| Senl-T7Patients will be treated with CD7 CAR-T cells | Biological | CD7 CAR-T |
Primary outcome
Safety: Incidence and severity of adverse events
Time frame: First 1 month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CD7
Remission Rate
Time frame: 3 months post CAR-T cells infusion
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
duration of response (DOR)
progression-free survival (PFS)
Time frame: 24 months post CAR-T cells infusion
progression-free survival (PFS) time
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
percentage of CD7 CAR- T cells measured by flow cytometry method
Cytokine release
Time frame: First 1 month post CAR-T cells infusion
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
Related trials for Lymphoma, T-Cell
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
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.
Peihua MD Lu, PhD principal investigator
Hebei Yanda Ludaopei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senl-T7 in people with Lymphoma, T-Cell, run by Hebei Senlang Biotechnology Inc., 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 1 inclusion and 1 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 31 May 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.
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 Peihua MD Lu, PhD (008618611636172, peihua_lu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and severity of adverse events (time frame: First 1 month post CAR-T cells infusion). The study lists 7 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 31 May 2022.