Actively Recruiting
A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia
Led by ImmunityBio, Inc. · Updated on 2026-04-29
10
Participants Needed
2
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1, open-label study to evaluate the safety and efficacy of CD19 t-haNK in patients with B-cell acute lymphoblastic leukemia. Up to 10 patients will receive at least 1 dose of study drug.
CONDITIONS
Official Title
A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older
- Able to provide informed consent according to ethics guidelines
- Confirmed diagnosis of pre B-cell acute lymphoblastic leukemia by histology or flow cytometry
- Experienced relapse after second complete remission, failed re-induction therapy, or positive minimal residual disease after induction
- Willing to undergo lumbar puncture for cerebrospinal fluid analysis and intrathecal chemotherapy
- Performance status: Lansky score above 60% for ages 12 to under 16, ECOG score 0 or 1 for ages 16 and older
- Expected survival longer than 16 weeks
- Willing to comply with study procedures
- Able to attend study visits and follow-up
- Agree to use effective contraception during study and for specified time after last dose (for females of childbearing potential and nonsterile males)
You will not qualify if you...
- Diagnosis of T-cell leukemia or Burkitt's M3 leukemia
- Known allergy or hypersensitivity to study medication components including sulfa-containing agents
- Poor organ function as shown by serum creatinine ≥ 2 mg/dL, liver enzymes (AST/ALT) ≥ 5 times upper normal limit, or total bilirubin ≥ 2 mg/dL
- Serious uncontrolled diseases that increase risk of treatment complications
- History or active significant autoimmune diseases requiring high-dose steroids
- History of allogeneic stem-cell transplant requiring ongoing graft versus host disease therapy
- History of organ transplant with immunosuppression
- Post solid organ transplant with high-grade lymphomas or leukemias
- Nonmalignant central nervous system diseases like stroke or epilepsy
- History or active inflammatory bowel disease
- Uncontrolled high blood pressure or serious cardiovascular conditions within 6 months
- Chronic daily systemic corticosteroid use over 20 mg prednisone equivalent for more than 3 months
- Use of medications known to interact adversely with study drugs
- HIV infection with low CD4 counts and detectable viral load
- Active hepatitis B infection
- Other active cancers except certain skin cancers
- Unable or unwilling to comply with protocol
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Dr Jackie Thomson Inc
Johannesburg, South Africa, 2193
Actively Recruiting
2
Alberts Cellular Therapy
Pretoria, South Africa, 0044
Actively Recruiting
Research Team
K
Kayleigh Russell
CONTACT
M
Mark Nelson
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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