Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL (NCT06641024) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL
China24 participantsStarted 2024-11-01
Plain-language summary
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic Leukemia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
. Age ≥ 18 years old (including threshold), gender not limited;
. Diagnosed with B-cell acute lymphoblastic leukemia and meeting one of the following conditions:
. Refractory B-ALL: Early refractory patients who have not achieved complete remission of bone marrow after two courses of first-line systemic therapy upon initial diagnosis;
. Relapsed B-ALL:
. Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they have relapsed/refractory disease despite treatment with at least 2 different tyrosine kinase inhibitors (TKIs); (Note: Except for those who are intolerant to TKI therapy, or have T315i mutations);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: 1 month
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
. Flow cytometry confirms the expression of CD19 in leukemia cells in the bone marrow. In individuals previously treated with targeted CD19 antibodies (such as blinatumomab), the proportion of CD19 positive cells in leukemia cells must be ≥ 90%;
. Morphological disease in the bone marrow (≥ 5% blasts);
Exclusion criteria
. Isolated extramedullary disease;
. Central nervous system abnormalities: defined as CNS-2 and 3 according to NCCN guidelines (note: CNS-2 and 3 can be screened, but must be treated and recovered to CNS-1 before lymphodepleting chemotherapy and infusion);
. Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;
. Individuals who have received CAR-T therapy or other gene modified cell therapies;
. Prior to apheresis, the following anti-tumor treatments have been received: chemotherapy, targeted therapy, and other drug treatments within 14 days or at least 5 half lives (whichever is shorter); Received radiation therapy within 14 days;
. HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive;
. Suffered from any of the following heart diseases:
. New York Heart Association (NYHA) stage III or IV congestive heart failure;