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

Not Applicable

Recruiting

Conditions: T-cell Acute Lymphoblastic Leukemia/Lymphoma

Interventions: Biological: Senl-T7

Registration Number: NCT05626400

Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Brief 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.

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 100

Inclusion Criteria

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;
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.

Exclusion Criteria

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;
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD-7 CART	Senl-T7	Patients will be treated with CD7 CAR-T cells

Primary Outcome Measures

Name	Time	Method
Safety: Incidence and severity of adverse events	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	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Hebei yanda Hospital
🇨🇳
Beijing, Hebei, China