OncoMatch/Clinical Trials/NCT07429461
Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia
Is NCT07429461 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies SYNCAR-100 for b-cell acute lymphoblastic leukemia.
Treatment: SYNCAR-100 — 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. Eligible participants will receive study drug administration once weekly for a total of four doses, followed by a 1-year safety and efficacy follow-up observation period. After the completion of the study, long-term follow-up may be required for participants to monitor their health and survival status until 15 years post-treatment, or until the occurrence of patient death, loss to follow-up, or withdrawal of consent.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (positive expression on tumor cells confirmed by flow cytometry)
Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood
Allowed: ABL1 fusion
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 is resistant to TKIs
Allowed: BCR fusion
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 is resistant to TKIs
Allowed: ABL1 T315I
the patient harbors the T315I mutation and is resistant to TKIs
Prior therapy
Must have received: standard induction chemotherapy — induction
Failure to achieve complete remission (CR) after 2 courses of standard induction chemotherapy
Must have received: salvage chemotherapy — salvage
failure to achieve CR after first-line/multiline salvage chemotherapy
Must have received: hematopoietic stem cell transplantation — post-transplant relapse
Relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
Must have received: tyrosine kinase inhibitor — Ph+ ALL
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
Cannot have received: hematopoietic stem cell transplantation
Exception: allowed if >6 months before enrollment
No prior hematopoietic stem cell transplantation (HSCT) within 6 months before enrollment
Cannot have received: CD19-targeted therapy
Prior receipt of CD19-targeted therapy
Cannot have received: CAR-T cell therapy
Prior receipt of CAR-T cell therapy
Cannot have received: gene-edited T cell therapy
Prior receipt of other gene-edited T cell therapy
Lab requirements
Blood counts
Absolute lymphocyte count (ALC) ≥ 0.1 × 10^9/L
Kidney function
Creatinine clearance > 60 mL/min (Cockcroft-Gault formula)
Liver function
ALT and AST < 2.5x ULN; for hepatic metastasis, ≤ 5x ULN; total bilirubin < 1.5x ULN; for Gilbert's syndrome, ≤ 3x ULN
Cardiac function
LVEF > 50% by echocardiography, no clinically significant pericardial effusion
Adequate organ function reserve, as defined by all of the following: Creatinine clearance > 60 mL/min; ALT and AST < 2.5x ULN (≤ 5x ULN with hepatic metastasis); total bilirubin < 1.5x ULN (≤ 3x ULN with Gilbert's); ALC ≥ 0.1 × 10^9/L; LVEF > 50% by echocardiography, no clinically significant pericardial effusion; no clinically significant pleural effusion; baseline peripheral oxygen saturation > 92% while breathing room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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