NCT07429461 Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia
| NCT ID | NCT07429461 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Zhejiang University |
| Condition | B-Cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2026-02-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2026-02-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT07429461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying B-Cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07429461 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07429461 currently recruiting?
Yes, NCT07429461 is actively recruiting participants. Visit ClinicalTrials.gov or contact Zhejiang University to inquire about joining.
Where is the NCT07429461 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07429461 clinical trial?
NCT07429461 is sponsored by Zhejiang University. The trial plans to enroll 16 participants.
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