Treatment of relapsed T-cell leukemia with Senl-T7 CAR T cells

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 study is testing a new type of CAR T cell treatment to see if it can help people with relapsed or hard-to-treat T-cell leukemia feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 2 Years to 70 Years
• Sex: All
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Beijingcun, Hebei)
• Trial ID: NCT05626400 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of Senl-T7 CAR T cells in patients with relapsed or refractory CD7+ acute T-cell lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). It is an open, prospective, dose-escalation study where patients will undergo preconditioning treatment before receiving the CAR T cell infusion. Following the infusion, patients will be monitored for adverse reactions and treatment efficacy, with pharmacokinetic and pharmacodynamic data collected throughout the process.

Who should consider this trial

Good fit: Ideal candidates are patients aged 2-70 years with relapsed or refractory CD7+ T-ALL or T-LBL who have a life expectancy greater than 12 weeks.

Not a fit: Patients with significant cardiac issues or those who do not express CD7 in their tumor cells may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed or refractory T-cell leukemia.

How similar studies have performed: Other studies using CAR T cell therapies have shown promising results in similar patient populations, indicating potential for success with this approach.

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.

Where this trial is running

Beijingcun, Hebei

• Hebei yanda Hospital — Beijingcun, Hebei, China (Recruiting)

Study contacts

• Study coordinator: Xian Zhang

Conditions T-cell Acute Lymphoblastic Leukemia/Lymphoma; T-ALL; T-LBL; CD7; CAR-T