RecruitingPhase 1

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study

China9 participantsStarted 2023-08-15

Plain-language summary

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. relapse: Primordial cells (\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears，include：
✓. Early recurrence within 12 months，
✓. Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy，
✓. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;
✓. Refractory: patients who have received at least two courses standard induction regimen and failed to achieve a complete response or complete remission was not achieved after first-line or above salvage treatment;
✓. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening;
✓. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry.
✓. Life expectancy greater than 12 weeks;

Exclusion criteria

✕. New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval \>480ms at screening (QTc interval calculated by Fridericia formula);
✕. If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;
✕. Those with active GvHD or those who require immunosuppressive therapy;
✕. Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;
✕. History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)
✕. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);
✕. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating medication within the past 2 years;
✕. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded;

What they're measuring

Safety: Incidence and severity of adverse events

Timeframe: 28 days after infusion

Trial details

NCT IDNCT06136364

SponsorHebei Senlang Biotechnology Inc., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-15

Contact for this trial

Weili Zhao, Dr

0311-82970973 zwl_trial@163.com

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