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New treatment option for B-Cell Acute Lymphoblastic Leukemia
Official title Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07429461
What this study is testing
What is SYNCAR-100 Injection?
SYNCAR-100 Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
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
- The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of SYNCAR-100 in patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). Participants who have signed the informed consent form will undergo screening against the inclusion and exclusion criteria.
- 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
- 1.Aged 18 to 75 years (inclusive), of any gender.
- 2.Karnofsky Performance Status score ≥ 70.
- 3.Estimated life expectancy ≥ 12 weeks.
- 4.Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood.
- 5.Confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) by bone marrow examination, and meeting one of the following criteria:
You likely can't join if
- 1.Isolated extramedullary leukemia or isolated extramedullary relapse.
- 2.Central nervous system (CNS) involvement of leukemia at CNS2 stage.
- 3.A history of other malignant tumors, except for the following: cured non-melanoma skin cancer, carcinoma in situ of the uterine cervix, localized...
- 4.Positive test results for any of the following infectious diseases: HIV; HCV; HBsAg; positive HBcAb with concurrent positive HBV DNA copy number...
- 5.Administration of live or attenuated live vaccines within 4 weeks prior to enrollment.
- 6.Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with tyrosine kinase inhibitor (TKI) therapy within 1 week prior to...
See the full eligibility criteria
Who can join
- 1.Aged 18 to 75 years (inclusive), of any gender.
- 2.Karnofsky Performance Status score ≥ 70.
- 3.Estimated life expectancy ≥ 12 weeks.
- 4.Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood.
- 5.Confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) by bone marrow examination, and meeting one of the following criteria:
- ① Refractory B-ALL: Failure to achieve complete remission (CR) after 2 courses of standard induction chemotherapy, or failure to achieve CR after first-line/multiline salvage chemotherapy.
- ② Relapsed B-ALL: Relapse within 12 months after the first remission, or relapse after first-line/multiline salvage chemotherapy.
- ③Relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT).
- ④ For Philadelphia chromosome-positive (Ph+) patients: At least 2 lines of tyrosine kinase inhibitor (TKI) therapy have failed, or the patient is intolerant to TKI therapy, or the patient harbors the T315I mutation and...
- 6.Proportion of blasts and immature lymphocytes in bone marrow \> 5% confirmed by bone marrow morphologic examination.
- 7.No prior hematopoietic stem cell transplantation (HSCT) within 6 months before enrollment.
- 8.Adequate organ function reserve, as defined by all of the following:
- ① Creatinine clearance (calculated by the Cockcroft-Gault formula) \> 60 mL/min: Male: Creatinine Clearance = [(140 - Age) × Body Weight (kg)] / [0.818 × Serum Creatinine (μmol/L)] Female: Creatinine Clearance = [(140 -...
- ② Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN) ; for patients with hepatic metastasis, AST and ALT ≤ 5 times the upper limit of normal (ULN) .
- ③Serum total bilirubin \< 1.5 times the upper limit of normal (ULN) ; for patients with Gilbert's syndrome, total bilirubin ≤ 3 times the upper limit of normal (ULN) .
- ④ Absolute lymphocyte count (ALC) ≥ 0.1 × 10\^9/L.
- ⑤Left ventricular ejection fraction (LVEF) \> 50% confirmed by echocardiography, with no clinically significant pericardial effusion on echocardiography.
- ⑥ No clinically significant pleural effusion.
- ⑦ Baseline peripheral oxygen saturation (measured at the fingertip) \> 92% while breathing room air.
- 9.For women of childbearing potential: Non-lactating; negative result of highly sensitive serum or urine pregnancy test during screening. All women of childbearing potential must use medically accepted contraceptive...
- 10.Ability to communicate effectively with investigators; willingness and ability to comply with the study protocol, complete all study-related procedures as required, and provide written informed consent (signed...
What rules you out
- 1.Isolated extramedullary leukemia or isolated extramedullary relapse.
- 2.Central nervous system (CNS) involvement of leukemia at CNS2 stage.
- 3.A history of other malignant tumors, except for the following: cured non-melanoma skin cancer, carcinoma in situ of the uterine cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ...
- 4.Positive test results for any of the following infectious diseases: HIV; HCV; HBsAg; positive HBcAb with concurrent positive HBV DNA copy number; TPPA.
- 5.Administration of live or attenuated live vaccines within 4 weeks prior to enrollment.
- 6.Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with tyrosine kinase inhibitor (TKI) therapy within 1 week prior to enrollment.
- 7.Prior receipt of CD19-targeted therapy, CAR-T cell therapy, or other gene-edited T cell therapy.
- 8.Grade ≥2 acute graft-versus-host disease (GVHD) (per Glucksberg criteria) requiring treatment, or extensive chronic GVHD (per Seattle criteria) within 4 weeks prior to enrollment; or patients judged by the...
- 9.Comorbidities judged by the investigator to require systemic corticosteroid therapy or other immunosuppressive therapy during the study period; or receipt of allogeneic cellular therapy (e.g., donor lymphocyte...
- 10.Receipt of CNS-directed radiotherapy within 4 weeks prior to enrollment.
- 11.Unresolved acute toxicities from prior therapy (excluding hematologic toxicities and alopecia) that have not recovered to Grade 1 or lower.
- 12.Known life-threatening hypersensitivity or other intolerance to the study drug, or a history of severe atopy.
- 13.Active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis...
- 14.Receipt of major surgery requiring general anesthesia within 4 weeks prior to enrollment; or failure to recover and achieve clinical stability from prior surgical treatment; or anticipated major surgery requiring...
- 15.Use of other investigational drugs within 28 days prior to enrollment.
- 16.A history of any unstable cardiovascular disease within 6 months prior to enrollment, including but not limited to unstable angina pectoris, myocardial infarction, heart failure (New York Heart Association [NYHA]...
- 17.A history of central nervous system (CNS) disease or disorders (e.g., seizure disorders, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease) or any autoimmune disease involving the CNS.
- 18.Uncontrolled active infection at screening (e.g., sepsis, bacteremia, fungemia, viremia).
- 19.Any other condition judged by the investigator to make the patient unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 Hangzhou, Zhejiang, 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.