A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia

April 22, 2026 updated by: ImmunityBio, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Up to 20 participants may be screened to enroll up to 10 patients who will receive at least 1 dose of study drug. The initial three participants will receive study drug in a staggered fashion, with a 7-day interval between each participant to evaluate the safety profile of the investigational product.

Patients will receive two 4-week cycles of IV CD19 t-haNK IV as a single agent regimen. Following a 1-week safety pause, patients will then receive 1 additional cycle of CD19 t-haNK given twice a week on an outpatient basis. Patients with no evidence of disease progression may be eligible to receive 2 additional cycles of treatment. Bone marrow aspirate will be performed for bone marrow analysis on day 22( +/- 3 days), and every 8 weeks( +/-1 week) thereafter. If there is no evidence of abnormal blasts present in bone marrow, measurable residual( MRD) testing will be performed. Treatment will be discontinued if a participant has confirmed progressive disease or unacceptable toxicity. Safety will be assessed for all participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Africa
      • Johannesburg, South Africa, 2193
      • Pretoria, South Africa, 0044
        • Recruiting
        • Alberts Cellular Therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 12 years old.
  2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.
  3. Histologically or flow cytometry documented pre B-ALL.
  4. Relapsed after achieving a 2nd complete remission (CR) or failed one cycle of re-induction therapy or with MRD positivity after ≥ 2 cycles of induction.
  5. Must be willing to undergo a lumbar puncture (LP) for CSF analysis and administration of IT chemotherapy.
  6. Performance status: Lansky score >60%, for participant ≥12 to <16 years. Eastern Cooperative Oncology Group (ECOG) score of ≤ 1 for participants ≥ 16 years.
  7. Expected survival > 16 weeks.
  8. Stated willingness to comply with study procedures.
  9. Able to attend required study visits and return for adequate follow-up, as required by this protocol.
  10. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), and implants such as intrauterine devices (IUDs).

All inclusion criteria must be answered "yes" for a participant to participate in the trial.

Exclusion Criteria:

  1. Participants with T-cell leukaemia and Burkitt's M3 leukaemia.
  2. Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).

  3. Inadequate organ function, evidenced by the following laboratory results:

    1. Serum creatinine ≥ 2 mg/dL
    2. Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≥ 5 upper limit of normal (ULN)
    3. Total bilirubin ≥ 2 mg/dL
  4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment related complications.
  5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as > 20 mg of prednisone or equivalent daily.
  6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.
  7. History of receiving allograft organ transplant requiring immunosuppression.
  8. Participants post solid organ transplant who develop high grade lymphomas or leukaemias.
  9. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).
  10. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  11. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.
  12. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids defined as > 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.
  13. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  14. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350 cells/μL and a detectable HIV viral load.
  15. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.
  16. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
  17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  18. Women who are pregnant or breastfeeding.

All exclusion criteria must be answered "no" for a participant to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CD19 t-haNK Arm
IV infusion of CD19 t-haNK
Drug: CD19 t-haNK
IV infusion of CD19 t-haNK

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate safety of CD19 t-haNK as a single agent in participants with selected CD19+ relapsed B-ALL.
Time Frame: up to 12 months post last dose of study drug
Incidence of TEAEs and SAEs graded using the NCI CTCAE Version 5.0 and clinically important changes in safety laboratory tests and vital signs.
up to 12 months post last dose of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Obtain preliminary estimates of efficacy of CD19 t-haNK in terms of bone marrow response.
Time Frame: up to 12 months post last dose of study drug
Bone marrow aspirate will be performed for bone marrow analysis on Day 22 (±3 days), and every 8 weeks (±1 week) thereafter.
up to 12 months post last dose of study drug
Obtain preliminary estimates of efficacy of CD19 t-haNK in terms of overall survival (OS)
Time Frame: up to 12 months post last dose of study drug
OS will be evaluated using Kaplan-Meier methods. OS will be defined as the time from the date of first treatment to the date of death (any cause).
up to 12 months post last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ImmunityBio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ResQ111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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