T-cell Acute Lymphoblastic Leukemia/LymphomaNCT05626400
Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL
A study testing Senl-T7 in people with T-cell Acute Lymphoblastic Leukemia/Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia/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
- 29 Aug 2022to 30 Dec 2027
- Phase
- Interventional
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%#;
- HGB≥70g/L（blood transfusion allowed）;
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hebei yanda Hospital
Beijingcun, Hebei
xian zhang, xian_zhang@126.com
About this study
Official title: Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T Lymphoblastic Leukemia and T Lymphoblastic Lymphoma
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.
- Being tested
- Senl-T7
- Keywords
- T-ALL, T-LBL, CD7, CAR-T
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma
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 |
|---|---|---|
| CD-7 CART | Experimental | Patients will be treated with CD7 CAR-T cells 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start29 Aug 2022
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic Leukemia/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
- NCT05626400
- Sponsor's protocol ID
- Senl-T7 CAR for T-ALL/T-LBL
- Status last verified
- Aug 2022
- First submitted
- 15 Nov 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No