Actively Recruiting
CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study
Led by Zhujiang Hospital · Updated on 2025-07-18
30
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.
CONDITIONS
Official Title
CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant voluntarily agrees to join the study and comply with visits and procedures
- Diagnosed with newly diagnosed or relapsed/refractory B-cell acute lymphoblastic leukemia including Burkitt lymphoma leukemia or blast-phase chronic myeloid leukemia
- Achieved complete remission after chemotherapy or immunotherapy
- Ineligible for allogeneic hematopoietic stem cell transplantation, lacks a suitable donor, or declines transplantation
- Age between 14 and 80 years, any gender
- ECOG performance status of 0 to 2
- Leukemia cells confirmed CD19-positive by flow cytometry
- Expected survival longer than 3 months from consent
- Adequate liver, kidney, heart, and lung function within specified laboratory limits
- Adequate venous access and meeting hematologic criteria for cell collection
- Female participants of childbearing potential must have negative pregnancy test
- Agreement to use contraception during the study for participants of reproductive potential
You will not qualify if you...
- Mixed-lineage leukemia or biphenotypic leukemia
- Prior CAR-T cell therapy before screening or conditioning
- Bone marrow failure syndromes linked to genetic disorders like Fanconi anemia or Kostmann syndrome
- Active viral infections including detectable hepatitis B DNA, positive hepatitis C antibody, detectable Epstein-Barr or cytomegalovirus DNA, or positive HIV antibody
- History or current malignancy within past 5 years except low-risk cases with long follow-up
- Severe heart conditions including advanced heart failure, serious arrhythmias, uncontrolled hypertension, recent heart attacks or surgeries
- Uncontrolled epilepsy or active central nervous system disorders
- Significant pericardial or pleural effusion at screening
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- Known allergies to study treatment components
- Live vaccine received within 6 weeks before screening
- Severe uncontrolled infections
- Participation in other interventional trials or recent investigational drug use
- Any other condition deemed unsuitable by investigator
- Physical or cognitive impairment preventing consent or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510200
Actively Recruiting
2
Zhujiang Hospital
Guangzhou, Guangdong, China, 510200
Actively Recruiting
Research Team
S
Sanfang Tu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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