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, a Prospective, Open, Multicenter, Randomized, Control Study (COMPLETE Study)
Led by Peking University People's Hospital · Updated on 2025-03-12
130
Participants Needed
1
Research Sites
104 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
Relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) often has poor prognosis with traditional salvage chemotherapy. Researchers are studying a targeted immunotherapy called Senl_B19 autologous CAR-T (S1904) treatment, which has shown high remission rates but short remission duration and high relapse risk. This study aims to evaluate whether adding an allogeneic hematopoietic stem cell transplant (allo-HSCT) after CAR-T treatment improves long-term survival and safety for R/R B-ALL patients. Participants will first receive the Senl_B19 autologous CAR-T (S1904) treatment. Those achieving bone marrow leukemia-free state and negative minimal residual disease within 12 weeks post-infusion will be randomly assigned to either a group receiving allo-HSCT transplant after CAR-T therapy or a group not receiving the transplant, in a 2:1 ratio. This setup allows comparison of outcomes with or without the bridging transplant. During the study, participants will be followed for an average of two years after randomization. Researchers will assess event-free survival, relapse-free survival, overall survival, and cumulative relapse incidence. The study includes regular monitoring of disease status and safety to understand the long-term effects of CAR-T therapy with or without allo-HSCT. The total participation duration varies but includes at least two years of follow-up.
CONDITIONS
Brief 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...
- The subject or guardian understands and voluntarily signs the Informed Consent Form
- Male or female aged between 12 and 65 years at consent
- Expected survival of at least 12 weeks
- ECOG performance score of 0-1 at consent
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia meeting specific relapse or refractory conditions
- For Philadelphia chromosome-positive ALL, must have failed at least two tyrosine kinase inhibitor treatments or be unable to tolerate them
- Bone marrow immature lymphocytes greater than 5% at screening
- CD19 positive tumor cells in bone marrow or peripheral blood at screening
- Liver and kidney function within defined limits
- Blood oxygen saturation higher than 92%
- Agree to use effective contraception from consent until 2 years after study drug use for those of childbearing potential
- 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 including epilepsy, stroke, severe brain injury, dementia, Parkinson's, or neuropathy except inactive CNS leukemia
- Previous hematopoietic stem cell transplantation
- Autoimmune disease requiring systemic immunosuppressive treatment within 2 years
- Uncontrolled active infection requiring treatment within 4 weeks before apheresis
- Previous CD19-targeted cell therapy
- Previous CAR-T or other cell/gene therapy before screening
- Positive tests for hepatitis B, C, HIV, CMV, EBV, or syphilis infections
- Significant cardiovascular disease including prolonged QTc, heart failure, recent myocardial infarction, low ejection fraction, uncontrolled hypertension, or arrhythmias
- Allergies to study drugs or clearance agents
- Recent anti-tumor treatments or radiotherapy within specified timeframes
- Unrecovered toxicities from previous treatments above grade 1 except alopecia and pigmentation
- Use of systemic corticosteroids or immunosuppressants above specified doses except certain exceptions
- Recent major surgery or expected surgery during study
- Active tuberculosis within 1 year
- Significant thyroid dysfunction
- History of interstitial lung disease or pneumonia
- Other primary malignancies within 5 years except specified skin and cervical cancers
- Recent or planned use of attenuated/inactivated vaccines
- Conditions or complications affecting protocol compliance
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks after CAR-T infusion for initial assessment and randomization
Participants receive Senl_B19 autologous CAR-T (S1904) treatment. If they achieve a bone marrow leukemia-free state and minimal residual disease negative within 12 weeks after infusion, they are randomized to either receive bridging allogeneic hematopoietic stem cell transplantation or not.
Visits as needed for treatment administration and monitoring during the 12 weeks
Duration - Approximately 2 years
Participants are followed for an average of 2 years after randomization to monitor event-free survival, relapse-free survival, cumulative incidence of relapse, and overall survival.
Regular follow-up visits for up to 2 years
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
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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