Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL (NCT06985498) | Clinical Trial Compass
SuspendedPhase 2
Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL
Stopped: According to the new regulations of China, newly launched clinical trials involved CAR-T cells must be apporved first by China National Center for Biotechology Development.
China40 participantsStarted 2025-06-01
Plain-language summary
Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR T and combination with other regimens may reduce the relapse rate. We conduct pre-auto-HSCT immunotherapy to achieve MRD negative remission, then perform auto-HSCT followed by CD22/CD19 CAR-T "sandwich " strategy in AYA and adult patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
Who can participate
Age range
15 Years – 65 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
. Newly diagnosed patients with Philadelphia chromosome (Ph)-negative B-cell acute lymphoblastic leukemia (B-ALL) or Ph-positive B-ALL in the high-risk group who have received standard induction chemotherapy; Patients with relapsed/refractory or MRD-positive B-ALL after any course of treatment without a history of immunotherapies（i.e. CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy）, who also meet any of the following criteria: (a) Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT). (b) Refuse allo-HSCT;
. positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry;
. cardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \> 91% without oxygenation;
. subjects aged 15-65 years (including 15 and 65 years), regardless of gender;
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
Overall survival
Timeframe: 2 years
Trial details
NCT IDNCT06985498
SponsorThe First Affiliated Hospital of Soochow University
. Patients who are relapsed/refractory or MRD-positive following treatment with CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy or allo-HSCT;
. Patients with KMT2A rearrangement
. patients with recurrence of only isolated extramedullary lesions;
. combination of other malignant tumors;
. previously treated with anti-CD19 or/and CD22 or/and CD3 therapies;
. immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent;
. Presence of bacterial, fungal, viral, mycoplasmal, or other types of infection that the investigator determines to be difficult to control;
. Patients with history of hepatitis B (HBsAg positive)or prior hepatitis B infection (defined as HBcAb positive, HBsAg negative) are eligible for enrollment provided that HBV DNA testing by PCR is negative; these subjects must undergo monthly PCR testing for HBV DNA. Patients with positive HCV antibody serology are eligible for enrollment if HCV RNA testing by PCR is negative. Positive for Treponema pallidum antibody (TP-Ab). Positive for human immunodeficiency virus (HIV) antibody.