ClinicalTrials.gg
RecruitingNCT05626400Updated Nov 25, 2022

Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL

An interventional study of Senl-T7 in T-cell Acute Lymphoblastic Leukemia/Lymphoma, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Recruiting at 1 site in China. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-25.

Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
2 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 51 studies in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma with a site in China — 27 open to participants now, 28 under way, 4 of them phase 3. Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · China.

Planned enrollment
4th of 50
100 · median 30
Started
2022
with 6 others
No phase
3 of 51
1 open now
Primary completion
2027-10
later than 18 of 27 live
Registered
27th of 51
by date
Lead sponsor
4 of 51
Hebei Senlang Biotechnology Inc., Ltd.

Among the 51 studies in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma with a site in China, this one is the 4th largest by planned enrollment of the 50 interventional ones that give a count, is one of 7 that started in 2022, is one of 3 with no phase, reaches primary completion later than 18 of the 27 other live ones, and was the 27th registered.

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

420 studies on the registry are indexed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; 75 are open to participants now.

Browse Precursor T-Cell Lymphoblastic Leukemia-Lymphoma studies →

Open to participants now

27 of the 51 studies in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma with a site in China are open now. Recruiting first, the newest first:

22 more — sign in →

All 27 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 59 Precursor T-Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 24 (41%) set no upper age limit and 30 (51%) stop at 75 or younger; 35 take children under 18; 1 takes healthy volunteers.

This study: 2 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study summary

This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.

Read the detailed description

The CARs consist of an anti-CD7 single-chain variable fragment(scFv), a portion of the human CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

03

Conditions studied

  • T-cell Acute Lymphoblastic Leukemia/Lymphoma

Keywords

  • T-ALL
  • T-LBL
  • CD7
  • CAR-T
04

Who can participate

Ages eligible
2 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of 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;
  2. CD7 expression in tumor cells was detected by flow cytometry;
  3. greater than 12 weeks;
  4. or Lansky score≥60;
  5. HGB≥70g/L (can be transfused);
  6. 2-70 years old;
  7. Oxygen saturation of blood#90%#;
  8. HGB≥70g/L(blood transfusion allowed);
  9. Total (TBil)≤3 × upper limit normal, (AST) and alanine aminotransferase (ALT) ≤ 5×;
  10. explained to, understood by and signed by patient/ guardian.

Exclusion criteria

Exclusion Criteria:

  1. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\<30% or (left ventricular ejection fraction)\<50%; or pericardial effusion. Cardiac dysfunction (New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
  2. Has an active GvHD;
  3. Has a history of severe pulmonary function damaging;
  4. With other tumors which is/are in advanced malignant and has/have systemic ;
  5. Severe or persistent infection that cannot be effectively controlled;
  6. Merging severe diseases or immunodeficiency disease;
  7. Patients with active or ([HBVDNA+]or [HCVRNA+]);
  8. Patients with infection or syphilis infection;
  9. Has a history of serious allergies on Biological products (including antibiotics);
  10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6;
  11. 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.;
  12. Have received transplant treatment for less than 6 months in prior to enrollment;
  13. Being pregnant and lactating or having pregnancy within 12 months;
  14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    CD-7 CART

    Patients will be treated with CD7 CAR-T cells

    Biological: Senl-T7

Interventions

  • BiologicalSenl-T7

    Patients will be treated with CD7 CAR-T cells

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: First 1 month post CAR-T cells infusion

  2. 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.

    Time frame: 3 months post CAR-T cells infusion

07

Study locations

1 of 1 sites recruiting
  • Hebei yanda Hospital
    Beijing, Hebei, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2022 (actual). Primary completion is estimated for Oct 2027, 62 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2022
First posted
Nov 23, 2022
StartActual
Aug 29, 2022
Primary completionEst.
Oct 30, 2027
CompletionEst.
Dec 30, 2027
Last update
Nov 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05626400
Responsible party
Sponsor
First posted
Nov 23, 2022
Start date
Aug 29, 2022
Primary completion
Oct 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Nov 25, 2022

Study contacts

Xian Zhang
Contact
xian_zhang@126.com
008618611636172
Jianqiang Li, MD, PhD
Contact
limmune@gmail.com
008615511369555

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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