BridgeMD
New treatment option for T-lymphoblastic Lymphoma
Official title CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study
ClinicalTrials.gov ID: NCT06136364
What this study is testing
What is CAR-T?
CAR-T is an investigational medicine, being studied as a potential treatment for t-lymphoblastic 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
- To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- According to the WHO hematopoietic and lymphoid tissue tumors classification, people with refractory/relapsing T-LBL/ALL has been adequately treated...
- relapse: Primordial cells (\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary...
- 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 ;
You likely can't join if
- Those who meet any of the following criteria are not eligible to join the group:
- New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina...
- If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell...
- 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...
- History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease...
See the full eligibility criteria
- According to the WHO hematopoietic and lymphoid tissue tumors classification, people with refractory/relapsing T-LBL/ALL has been adequately treated and there is a lack of effective treatment, met one of the following...
- 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;
- ECOG 0-2;
- Age 18-75 (upper and lower limits included);
- HGB at least 70g/L,PLT 50x109/L, can be transfused;
- Liver and kidney functions The cardiopulmonary functions meet the following requirements:
- Oxygen saturation under air ≥ 92%;
- LVEF≥50%;
- Total bilirubin \<3×ULN;
- ALT/AST\<3×ULN;
- Creatinine \ 50ml/min;
- Informed consent explained to, understood by and signed by patient/ guardian.
- Those who meet any of the following criteria are not eligible to join the group:
- 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...
- 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...
- 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...
- Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug...
- History of severe allergy to biological products;
- Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy;
- Pregnant or breastfeeding women, and female people planning pregnancy within 2 years of cell infusion or male people whose partner is planning pregnancy within 2 years of cell infusion;
- people who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
- Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.