Actively Recruiting
Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cell Acute Lymphoblastic Leukemia
Led by Peking University People's Hospital · Updated on 2025-03-12
130
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
T
The First Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Traditional salvage chemotherapy has low efficacy and poor long-term prognosis for relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Targeted CD19 CAR-T cell immunotherapy is an effective means of treating R/R B-ALL. Several clinical studies have shown that its remission rate for R/R B-ALL can reach 68-93%. However, long-term follow-up found that the remission time after CD19 CAR-T treatment is short and the relapse rate is high. Therefore, how to ensure the long-term survival of R/R B-ALL patients after remission by CAR-T therapy is an urgent problem to be solved. Some studies have shown that timely bridging allo-HSCT after CAR-T treatment can overcome the risk of relapse and further improve the long-term survival of patients. However, there is currently no randomized controlled study on whether to bridge transplantation after CAR-T. The purpose of this study is to evaluate the efficacy and safety of S1904 in the treatment of relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia with or without bridging to allogeneic hematopoietic stem cell transplantation after remission.
CONDITIONS
Official Title
Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or guardian voluntarily signs informed consent
- Male or female aged 12 to 65 years
- Expected survival of at least 12 weeks
- ECOG physical performance score of 0 or 1
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia meeting relapse or refractory definitions
- For Philadelphia chromosome-positive ALL, must have failed at least two tyrosine kinase inhibitor treatments or be intolerant/contraindicated
- Bone marrow immature lymphocytes >5% at screening
- Tumor cells in bone marrow or blood are CD19 positive
- Adequate major organ function as defined by liver enzymes, bilirubin, and kidney function
- Blood oxygen saturation above 92%
- Agree to use effective contraception from consent signing until 2 years after study drug use
- Negative pregnancy test for females of childbearing potential at screening
You will not qualify if you...
- Isolated extramedullary relapse
- Burkitt's lymphoma/leukemia
- History of CNS diseases such as epilepsy, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, or neuropathy (except inactive CNS leukemia)
- Previous hematopoietic stem cell transplantation
- Autoimmune diseases requiring systemic immunosuppressive treatment within 2 years
- Uncontrolled active infection requiring treatment within 4 weeks before apheresis
- Previous CD19 targeted cell therapy or CAR-T therapy
- Positive tests for hepatitis B, hepatitis C, HIV, cytomegalovirus, Epstein-Barr virus, or syphilis antibodies
- Significant cardiovascular diseases including prolonged QTc, heart failure, unstable angina, recent myocardial infarction, reduced ejection fraction, poorly controlled hypertension, or arrhythmias
- Allergy to study drugs or clearing agents
- Recent systemic anti-tumor treatments or extensive radiotherapy within specified timeframes
- Unresolved toxicity from prior treatments above grade 1 except alopecia and pigmentation
- Requirement for systemic corticosteroids or immunosuppressive drugs above defined limits
- Major surgery within 4 weeks or planned during study
- Active tuberculosis within 1 year
- Significant thyroid dysfunction
- History or presence of interstitial lung disease or pneumonia
- Other primary cancers within 5 years except certain treated skin or cervical cancers
- Recent or planned attenuated/inactivated vaccinations
- Conditions affecting protocol compliance or suitability
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People'S Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yu Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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