To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL
NCT ID:
NCT05626400
Condition:
T-cell Acute Lymphoblastic Leukemia/Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
T-ALL
T-LBL
CD7
CAR-T
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Senl-T7
Description:
Patients will be treated with CD7 CAR-T cells
Arm group label:
CD-7 CART
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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；
2. CD7 expression in tumor cells was detected by flow cytometry；
3. Life expectancy greater than 12 weeks；
4. KPS 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 bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
10. Informed consent explained to, understood by and signed by patient/ guardian.
Exclusion Criteria:
1. 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);
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
metastasis;
5. Severe or persistent infection that cannot be effectively controlled;
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
8. Patients with HIV 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.
Gender:
All
Minimum age:
2 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hebei yanda Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
xian zhang
Email:
xian_zhang@126.com
Start date:
August 29, 2022
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Hebei Senlang Biotechnology Inc., Ltd.
Agency class:
Industry
Source:
Hebei Senlang Biotechnology Inc., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05626400
