Actively Recruiting
A Phase 1 Open-label Study of CD19 t-hANK as a Single Agent in Participants With Selected CD19+ Relapsed B-cell Acute Lymphoblastic Leukemia
Led by ImmunityBio, Inc. · Updated on 2026-04-29
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of CD19 t-haNK, an investigational drug, in patients aged 12 years and older with relapsed B-cell acute lymphoblastic leukemia (B-ALL). This phase 1, open-label trial aims to evaluate how patients respond to this treatment and monitor any side effects. The study focuses on patients who have relapsed after remission or have measurable residual disease following prior treatment cycles. Participants will receive CD19 t-haNK through intravenous infusions. Initially, three patients will receive doses spaced one week apart to assess safety. Treatment involves two 4-week cycles of the drug as a single agent, followed by a one-week safety pause, then an additional cycle with twice-weekly doses on an outpatient basis. Patients without disease progression may receive up to two more cycles. Bone marrow samples will be collected to monitor disease status, and treatment will stop if the disease worsens or if unacceptable side effects occur. During the trial, patients will undergo bone marrow aspirates for analysis around day 22 and every eight weeks thereafter. If no abnormal cells are found, further testing for minimal residual disease will be done. Safety assessments will be performed throughout, including monitoring for adverse reactions up to 12 months after the last dose. The study involves regular visits and follow-ups to evaluate both safety and preliminary effectiveness of the treatment over time.
CONDITIONS
Brief 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 understand and provide signed informed consent
- Diagnosis of pre B-cell acute lymphoblastic leukemia confirmed by histology or flow cytometry
- Relapsed after second complete remission, failed one cycle of re-induction therapy, or MRD positive after at least two induction cycles
- Willing to undergo lumbar puncture for cerebrospinal fluid analysis and intrathecal chemotherapy
- Performance status: Lansky score above 60% for ages 12 to less than 16 years, ECOG score 1 or less for ages 16 years and older
- Expected survival longer than 16 weeks
- Willing to comply with study procedures
- Able to attend all required study visits and follow-up
- Agreement to practice effective contraception during study and specified period 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 substances
- Inadequate organ function shown by serum creatinine 2 mg/dL or higher, AST/ALT 5 times above normal, or total bilirubin 2 mg/dL or higher
- Serious uncontrolled diseases that increase risk for treatment complications
- History of significant autoimmune diseases or active uncontrolled autoimmune conditions requiring steroid therapy above 20 mg prednisone daily
- History of allogeneic hematopoietic stem-cell transplantation with ongoing graft versus host disease therapy
- History of organ transplant requiring 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 significant cardiovascular events in the past 6 months
- Chronic daily systemic corticosteroid treatment over 3 months exceeding 20 mg prednisone or equivalent, excluding inhaled steroids
- Taking medications known to interact adversely with the study drugs
- HIV infection with low CD4 count and detectable viral load
- Active hepatitis B infection
- Other active cancers except certain skin cancers
- Unable or unwilling to comply with study requirements
- Pregnant or breastfeeding women
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.
Up to 20 participants may be screened to enroll up to 10 patients
Duration - Two 4-week cycles followed by a 1-week safety pause, then 1 additional cycle; up to 2 additional cycles may be given if no disease progression
Participants receive intravenous infusions of CD19 t-haNK as a single agent regimen in cycles.
IV infusions twice a week during cycles; bone marrow aspirate on day 22 (+/- 3 days) and every 8 weeks (+/- 1 week) thereafter
Duration - Up to 12 months post last dose
Safety and efficacy assessments continue for up to 12 months after the last dose of study drug.
Scheduled visits to evaluate safety and overall survival
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
M
Mark Nelson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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