BridgeMD
New treatment option for T-cell Acute Lymphoblastic Leukemia/Lymphoma
Official title Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL
ClinicalTrials.gov ID: NCT05626400
What this study is testing
What is Senl-T7?
Senl-T7 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t-cell acute lymphoblastic leukemia/lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 70
You may be able to join if
- Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete...
- 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);
You likely can't join if
- Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or...
- 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;
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijingcun, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijingcun, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.