Actively Recruiting
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
Led by National University of Malaysia · Updated on 2025-05-29
10
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
N
National University of Malaysia
Lead Sponsor
G
Gaia Science
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia
CONDITIONS
Official Title
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory B-Acute Lymphoblastic Leukemia confirmed by WHO classification
- Age between 13 and 65 years
- No detectable leukemia in cerebrospinal fluid (CNS-1)
- CNS leukemia without neurological symptoms (CNS-2) with <5 white blood cells per microliter and positive blast cytology
- Adequate organ function: creatinine clearance > 50 ml/min, total bilirubin < 5 times normal, left ventricular ejection fraction > 40%
- ECOG performance status 0 to 2
- Life expectancy greater than 3 months
- At least 100 days post allogeneic hematopoietic stem cell transplant with no active graft-versus-host disease and not on immunosuppression
- Female patients of childbearing potential must have a negative pregnancy test and use effective contraception
- Male patients must use effective contraception
You will not qualify if you...
- Patients with CNS-3 leukemia
- Active cancer other than B-Acute Lymphoblastic Leukemia
- Severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, renal failure, or severe neurological disorder
- Active autoimmune disease or severe allergy
- Positive HIV test
- Active Hepatitis B or C infection confirmed by viral PCR
- Uncontrolled sepsis
- Pregnant or nursing females
- Ongoing treatment with prednisolone greater than 1 mg/kg daily or equivalent
- Chemotherapy or immunotherapy within the past 4 weeks, including allogeneic cellular therapy and anti-GVHD therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UKM Medical Centre
Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
Research Team
S
S Fadilah Abdul Wahid, MD, DrIntMed, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here