T-ALLPhase 1NCT05398614
SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory CD7+ Hematolymphoid Malignancies
A Phase 1 study testing SENL101 in people with T-ALL and Lymphoma, T-Cell, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- T-ALL, Lymphoma, T-Cell
- What is being tested?
- SENL101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Jun 2024
- Phase
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with refractory/relapsing T-cell leukaemia/lymphoma met one of the following criteria: relapse: disease recurrence after complete remission with at least two prior regiments or complete remission with stem cell transplantation; Refractory: patients who have received at least two previous treatment regimens and failed to achieve a complete or partial response after the last treatment (leukemia patients), or failed to achieve a response after stem cell transplantation or develop disease progression;
- The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening;
- If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry. If the surface phenotype of peripheral blood tumor cells was not CD4 and CD8 double negative, the proportion of tumor cells in peripheral blood was ≤1%;
- Life expectancy greater than 12 weeks;
- ECOG 0-2;
- Age 18-65 (upper and lower limits included);
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- HGB at least 70g/L,PLT 20x109/L, can be transfused;
- Liver and kidney functions The cardiopulmonary functions meet the following requirements: Oxygen saturation under air ≥ 92%; LVEF≥45%; Total bilirubin <3×ULN; ALT/AST<5×ULN; Creatinine <1.5×ULN;
- Informed consent explained to, understood by and signed by patient/ guardian.
Who cannot join
- Those who meet any of the following criteria are not eligible to join the group:
- New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval >480ms at screening (QTc interval calculated by Fridericia formula);
- If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;
- Those with active GvHD or those who require immunosuppressive therapy;
- Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;
- Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);
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- History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating medication within the past 2 years;
- When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded;
- Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer);
- History of severe allergy to biological products;
- Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy;
- Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion;
- Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
- Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei
Liang Huang, 027-83691785, tongjilunli@163.com
About this study
Official title: Early Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory CD7+ Hematolymphoid Malignancies
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.
Read the detailed description
Main research purposes:
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.
Secondary research purposes:
To preliminarily evaluate the efficacy, pharmacokinetics and pharmacodynamics of SENL101 in the treatment of patients with relapsed or refractory CD7+ hemolymphoid malignancies.
Exploratory research purpose：
- To explore the immunogenicity of SENL101；
- T cell NK cell recovery time after treatment；
- Other indicators of interest to researchers。
- Conditions
- T-ALL, Lymphoma, T-Cell
- Being tested
- SENL101
- Keywords
- CD7, T-ALL/T-LBL
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENL101Biological
Patients will be treated with CD7 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| CD7 CAR-T | Experimental | SENL101 Receives: Biological: SENL101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and severity of adverse events
The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period
Measured: 24 months 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 posted1 Jun 2022
- Study start1 May 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-ALLStudies 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
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liang Huang, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398614
- Sponsor's protocol ID
- SENL101 for CD7+
- Status last verified
- Apr 2022
- First submitted
- 20 May 2022
- Last updated
- 1 Jun 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory CD7+ Hematolymphoid Malignancies
- ClinicalTrials.gov ID
- NCT05398614
- Acronym / sponsor ID
- SENL101 for CD7+
- Conditions
- T-ALL, Lymphoma, T-Cell
- Keywords
- CD7, T-ALL/T-LBL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Jun 2022 (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 evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.
Detailed description
Main research purposes:
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.
Secondary research purposes:
To preliminarily evaluate the efficacy, pharmacokinetics and pharmacodynamics of SENL101 in the treatment of patients with relapsed or refractory CD7+ hemolymphoid malignancies.
Exploratory research purpose：
- To explore the immunogenicity of SENL101；
- T cell NK cell recovery time after treatment；
- Other indicators of interest to researchers。
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: SENL101SENL101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects diagnosed with refractory/relapsing T-cell leukaemia/lymphoma met one of the following criteria: relapse: disease recurrence after complete remission with at least two prior regiments or complete remission with stem cell transplantation; Refractory: patients who have received at least two previous treatment regimens and failed to achieve a complete or partial response after the last treatment (leukemia patients), or failed to achieve a response after stem cell transplantation or develop disease progression;
- The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening;
- If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry. If the surface phenotype of peripheral blood tumor cells was not CD4 and CD8 double negative, the proportion of tumor cells in peripheral blood was ≤1%;
- Life expectancy greater than 12 weeks;
- ECOG 0-2;
Key exclusion criteria (14 listed)
- New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval >480ms at screening (QTc interval calculated by Fridericia formula);
- If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;
- Those with active GvHD or those who require immunosuppressive therapy;
- Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;
- Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);
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 |
|---|---|---|
| SENL101Patients will be treated with CD7 CAR-T cells | Biological | CD7 CAR-T |
Primary outcome
Safety: Incidence and severity of adverse events
Time frame: 24 months post CAR-T cells infusion
The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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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.
Liang Huang study director
Tongji Hospital
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 SENL101 in people with T-ALL and 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 9 inclusion and 14 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 1 Jun 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Huang (027-83691785, tongjilunli@163.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: 24 months post 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 1 Jun 2022.