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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hebei yanda Hospital
  Beijingcun, Hebei, China Recruiting

Study contacts

• Study coordinator: Xian Zhang
• Email: xian_zhang@126.com
• Phone: 008618611636172

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using anti-CD7 CAR-T cells to treat relapsed or refractory T-Cell leukemia or lymphoma

  This study is testing a new CAR-T cell therapy called BEAM-201 to see if it can help young people with tough-to-treat T-Cell leukemia or lymphoma feel better and achieve remission.

  Recruiting Phase 1 Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT06934382

• New treatment approach for children newly diagnosed with T‑cell acute lymphoblastic leukemia using dasatinib, venetoclax, and homoharringtonine

  This study will try adding dasatinib, venetoclax, and homoharringtonine to standard chemotherapy for children and adolescents newly diagnosed with T‑cell acute lymphoblastic leukemia to see if it increases deep (MRD‑negative) remissions and lowers relapse.

  Recruiting Phase 2/3 Institute of Hematology & Blood Diseases Hospital, China · Hefei, Anhui and 26 other locations · NCT06855810

• CD7-CAR-T cell therapy for children with relapsed or refractory T-cell leukemia

  This study is testing a new CAR-T cell therapy for children with hard-to-treat T-cell leukemia to see if it can help them when other treatments have not worked.

  Recruiting Phase 1/2 Bambino Gesù Hospital and Research Institute · Rome, Rome · NCT06064903

• Long-term follow-up registry for Kymriah (tisagenlecleucel) in South Korea

  This project will follow people in Korea with B-cell leukemias or lymphomas who received Kymriah to see if the treatment stays safe and continues to work well over many years.

  Recruiting at 18 sites Novartis · Bundang Gu, Gyeonggi-do and 17 other locations · NCT06785818

• Collecting blood samples from patients treated with CAR-T cells for blood cancers

  This study is collecting blood samples from patients with lymphoma and Acute Lymphoblastic Leukemia who have been treated with CAR-T cells to see what factors affect how well the treatment works.

  Recruiting University Hospital, Montpellier · Montpellier · NCT04290000

• CD180 CAR-T for relapsed or refractory CD180-positive blood cancers

  This trial will test whether an intravenous CD180 CAR‑T cell therapy can help adults with relapsed or refractory CD180‑positive AML or B‑ALL/LBL.

  Recruiting Phase 1 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07106749

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.