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 (Jun 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
Treatments studied
Other
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
Demographics
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.
Frequently asked questions
Is NCT07429461 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplantation, CD19-targeted therapy, CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages