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New treatment option for Relapsed Adult ALL
Official title Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06581081
What this study is testing
What is Senl_B19 autologous CAR-T (S1904) treatment?
Senl_B19 autologous CAR-T (S1904) treatment is an investigational medicine, being studied as a potential treatment for relapsed adult all.
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
- Traditional salvage chemotherapy has low efficacy and poor long-term prognosis for relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Targeted CD19 CAR-T cell immunotherapy is an effective means of treating R/R B-ALL.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- The subject or guardian understands and voluntarily signs the Informed Consent Form (ICF);
- Male or female, aged 12-65 years (including the cutoff value) when signing the informed consent form;
- Expected survival period is not less than 12 weeks;
- ECOG physical performance score is 0-1 when signing the ICF;
- The subject must be diagnosed with relapsed/refractory B-cell acute lymphoblastic leukemia when signing the ICF, and at least one of the following...
You likely can't join if
- Isolated extramedullary relapse;
- Burkitt's lymphoma/leukemia;
- Previous history of CNS disease, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's...
- Previous hematopoietic stem cell transplantation;
- History of autoimmune disease requiring systemic immunosuppressive drug treatment within 2 years before signing the ICF (including but not limited to...
- Any uncontrolled active infection at the time of signing the ICF or within 4 weeks before apheresis, requiring antibiotic, antiviral or antifungal...
See the full eligibility criteria
Who can join
- The subject or guardian understands and voluntarily signs the Informed Consent Form (ICF);
- Male or female, aged 12-65 years (including the cutoff value) when signing the informed consent form;
- Expected survival period is not less than 12 weeks;
- ECOG physical performance score is 0-1 when signing the ICF;
- The subject must be diagnosed with relapsed/refractory B-cell acute lymphoblastic leukemia when signing the ICF, and at least one of the following must be met:
- Relapse: including relapse within 12 months after the first remission, 2 or more relapses;
- Refractory: including primary refractory, failure to achieve remission after at least 2 courses of induction therapy, or failure to achieve remission after at least 1 course of salvage therapy after the first relapse.
- For patients with Philadelphia chromosome-positive ALL (Ph+ ALL), in addition to meeting the above relapse or refractory criteria, they should have failed at least two tyrosine kinase inhibitor (TKI) treatments (except...
- Bone marrow morphology examination at screening showed that the proportion of primitive immature lymphocytes in the bone marrow was \>5%;
- Tumor cells in the bone marrow or peripheral blood were CD19 positive by flow cytometry at screening;
- Major organ functions must meet the following requirements:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN);
- Total bilirubin ≤2×ULN;
- Serum creatinine clearance of adult people ≥60 mL/min (Cockcroft-Gault formula) or creatinine ≤1.5×upper limit of normal (ULN);
- Serum creatinine for children: no more than 1.2 mg/dL for 10 to 13 years old, no more than 1.5 mg/dL for males aged 13 to 16 years old, no more than 1.4 mg/dL for females aged 13 years and above, and no more than 1.7...
- Blood oxygen saturation\>92%;
- Males and females of childbearing age with fertility must agree to use effective contraceptive measures from the signing of the informed consent form until 2 years after the use of the study drug. Females of...
What rules you out
- Isolated extramedullary relapse;
- Burkitt's lymphoma/leukemia;
- Previous history of CNS disease, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy (except inactive CNS leukemia);
- Previous hematopoietic stem cell transplantation;
- History of autoimmune disease requiring systemic immunosuppressive drug treatment within 2 years before signing the ICF (including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus...
- Any uncontrolled active infection at the time of signing the ICF or within 4 weeks before apheresis, requiring antibiotic, antiviral or antifungal treatment;
- Previous cell therapy targeting CD19 (autologous or allogeneic);
- Received CAR-T therapy or other cell/gene therapy before screening;
- Those who tested positive for hepatitis B surface antigen (HBsAg) during screening need to be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, those with peripheral blood hepatitis B...
- Clinically significant cardiovascular disease, including any of the following:
- QTc interval ≥470 ms after heart rate correction (QTc interval calculated by Fridericia formula);
- New York Heart Association (NYHA) grade II or above heart failure;
- Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
- Left ventricular ejection fraction (LVEF) \< 50%;
- Poorly controlled hypertension (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 95 mm Hg);
- Arrhythmias with clinical significance or requiring antiarrhythmic treatment (such as sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes tachycardia and complete left bundle branch block...
- Allergic to any drug component to be used in this study, including but not limited to S1904, clearing drugs (cyclophosphamide, fludarabine), etc.;
- Received any study drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is more appropriate as determined by the researcher);
- Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy of non-target lesions for symptom relief within 2 weeks before signing the ICF or expected during the study period;
- At the time of signing the ICF, except for alopecia and pigmentation, the toxicity caused by previous anti-tumor treatment has not recovered to grade 1 or baseline level (according to NCI-CTCAE version 5.0);
- Patients who need to receive systemic corticosteroids (dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 2 weeks before signing the ICF or within 2 weeks before apheresis...
- Intranasal, inhaled, local steroids or local steroid injections (such as intra-articular injections), or
- Systemic corticosteroid treatment not exceeding 10 mg/day of prednisone or its equivalent physiological dose, or
- Steroids as a preventive medication for allergic reactions (such as pretreatment before computed tomography [CT]), or
- Used for symptomatic treatment of adverse reactions after reinfusion;
- people who have undergone major surgery (except routine biopsy) within 4 weeks before signing the ICF, or are expected to undergo major surgery during the study;
- people with a history of active tuberculosis infection within 1 year before signing the ICF (except for people with a history of active tuberculosis infection more than 1 year ago who are judged by the investigator to...
- people with clinically significant thyroid dysfunction as judged by the investigator;
- people with or with a history of interstitial lung disease or interstitial pneumonia;
- people with a history of other primary malignant tumors within 5 years before signing the ICF, except for the following:
- Cervical carcinoma in situ that has been fully treated and cured;
- Localized basal cell carcinoma or squamous cell carcinoma of the skin;
- people who have received attenuated/inactivated vaccines within 4 weeks before signing the ICF, or people who are planned to receive attenuated/inactivated vaccines during the screening period;
- The researcher believes that the subject's complications or other conditions may affect compliance with the protocol or may be unsuitable for participation in this study;
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.