SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaNCT04916860
Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
A study testing Senl-T7 in people with SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
- 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
- Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；
- CD7 expression in tumor cells was detected by flow cytometry；
- Life expectancy greater than 12 weeks；
- KPS or Lansky score≥60;
- HGB≥70g/L (can be transfused);
- 2-70 years old;
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- oxygen saturation of blood#90%#;
- Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
- Informed consent explained to, understood by and signed by patient/ guardian.
Who cannot join
- Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
- Has an active GvHD;
- Has a history of severe pulmonary function damaging;
- With other tumors which is/are in advanced malignant and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Merging severe autoimmune diseases or immunodeficiency disease;
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- Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA
- +]);
- Patients with HIV infection or syphilis infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6.
- Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
- Have received transplant treatment for less than 6 months in prior to enrollment;
- Being pregnant and lactating or having pregnancy within 12 months;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma
Read the detailed description
This study is an open, prospective, dose-increasing clinical study with patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma as subjects. In order to evaluate the safety and efficacy of SENL-T7 in patients with CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, the PK/PD indicators of SENL-T7 are also collected. In this study, no dose grouping is set, and 0.5-2E6 /kg× actual body weight dose is selected for reinfusion according to patients' disease diagnosis and tumor load.
The Main research objectives:
To evaluate the safety and efficacy of SENL-T7 in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
The Secondary research objectives:
To investigate the cellular dynamics of SENL-T7 CAR T cells in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
- Conditions
- SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
- Being tested
- Senl-T7
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 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Measured: First 1 month post CAR-T cells infusion
Remission Rate
To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation.
Measured: 3 months post CAR-T cells infusion
Secondary outcomes (5)
duration of response (DOR)
duration of response (DOR)
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
progression-free survival (PFS)
progression-free survival (PFS) time
Measured: 24 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
Measured: First 1 month 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start27 Jan 2021
- Primary completion31 Jan 2023
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916860
- Sponsor's protocol ID
- SenL-T7 for CD7+leukemia/T-LBL
- Status last verified
- Mar 2023
- First submitted
- 1 Jun 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cao XY, Zhang JP, Wei ZJ, Lu Y, Zhao YL, Xiong M, Zhou JR, Wang Y, Yang JF, Zhang X, Li J, Lu P. Long-Term Outcomes of Second Allogeneic Transplantation Following CD7 CAR-T in Remission for T-Cell Acute Lymphoblastic Leukemia or Lymphoma. Transplant Cell Ther. 2026 Aug;32(8):956.e1-956.e13. doi: 10.1016/j.jtct.2026.05.045. Epub 2026 Jun 1.
PubMed 42229585
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. 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 and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT04916860
- Acronym / sponsor ID
- SenL-T7 for CD7+leukemia/T-LBL
- Conditions
- SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
- 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 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 8 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 is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma
Detailed description
This study is an open, prospective, dose-increasing clinical study with patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma as subjects. In order to evaluate the safety and efficacy of SENL-T7 in patients with CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, the PK/PD indicators of SENL-T7 are also collected. In this study, no dose grouping is set, and 0.5-2E6 /kg× actual body weight dose is selected for reinfusion according to patients' disease diagnosis and tumor load.
The Main research objectives:
To evaluate the safety and efficacy of SENL-T7 in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
The Secondary research objectives:
To investigate the cellular dynamics of SENL-T7 CAR T cells in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic 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 (9 listed)
- Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；
- CD7 expression in tumor cells was detected by flow cytometry；
- Life expectancy greater than 12 weeks；
- KPS or Lansky score≥60;
- HGB≥70g/L (can be transfused);
Key exclusion criteria (15 listed)
- Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
- Has an active GvHD;
- Has a history of severe pulmonary function damaging;
- With other tumors which is/are in advanced malignant and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
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 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Remission Rate
Time frame: 3 months post CAR-T cells infusion
To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation.
5 secondary outcomes
duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
progression-free survival (PFS)
Time frame: 24 months post CAR-T cells infusion
Cytokine release
Time frame: First 1 month post CAR-T cells infusion
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 42229585Cao XY, Zhang JP, Wei ZJ, Lu Y, Zhao YL, Xiong M, Zhou JR, Wang Y, Yang JF, Zhang X, Li J, Lu P. Long-Term Outcomes of Second Allogeneic Transplantation Following CD7 CAR-T in Remission for T-Cell Acute Lymphoblastic Leukemia or Lymphoma. Transplant Cell Ther. 2026 Aug;32(8):956.e1-956.e13. doi: 10.1016/j.jtct.2026.05.045. Epub 2026 Jun 1.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma, 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 15 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 Mar 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 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?
On the ClinicalTrials.gov record for NCT04916860, which also lists 1 linked publication.
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 Mar 2023.