B-ALLPhase 1NCT07556757
A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia
A Phase 1 study testing CD19 t-haNK in people with B-ALL and Leukemia, run by ImmunityBio, Inc. at 2 sites in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- CD19 t-haNK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 11 Apr 2025to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.
- Histologically or flow cytometry documented pre B-ALL.
- 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.
- Must be willing to undergo a lumbar puncture (LP) for CSF analysis and administration of IT chemotherapy.
- Performance status: Lansky score >60%, for participant ≥12 to <16 years. Eastern Cooperative Oncology Group (ECOG) score of ≤ 1 for participants ≥ 16 years.
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- Expected survival > 16 weeks.
- Stated willingness to comply with study procedures.
- Able to attend required study visits and return for adequate follow-up, as required by this protocol.
- 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.
Who cannot join
- Participants with T-cell leukaemia and Burkitt's M3 leukaemia.
- Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).
- Inadequate organ function, evidenced by the following laboratory results:
- Serum creatinine ≥ 2 mg/dL
- Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≥ 5 upper limit of normal (ULN)
- Total bilirubin ≥ 2 mg/dL
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- 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.
- 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.
- History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.
- History of receiving allograft organ transplant requiring immunosuppression.
- Participants post solid organ transplant who develop high grade lymphomas or leukaemias.
- Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- 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.
- 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.
- Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
- History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350 cells/μL and a detectable HIV viral load.
- Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.
- Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Women who are pregnant or breastfeeding.
- All exclusion criteria must be answered "no" for a participant to participate in the trial.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Dr Jackie Thomson Inc
Johannesburg, 2193
Alberts Cellular Therapy
Pretoria, 0044
About this study
Official title: 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.
Read the 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.
- Being tested
- CD19 t-haNK
- Keywords
- B-Cell, Acute, Lymphoblastic
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 t-haNKDrug
IV infusion of CD19 t-haNK
| Study group | Role | What they receive |
|---|---|---|
| CD19 t-haNK Arm | Experimental | IV infusion of CD19 t-haNK Receives: Drug: CD19 t-haNK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety of CD19 t-haNK as a single agent in participants with selected CD19+ relapsed B-ALL.
Incidence of TEAEs and SAEs graded using the NCI CTCAE Version 5.0 and clinically important changes in safety laboratory tests and vital signs.
Measured: up to 12 months post last dose of study drug
Secondary outcomes (2)
Obtain preliminary estimates of efficacy of CD19 t-haNK in terms of bone marrow response.
Bone marrow aspirate will be performed for bone marrow analysis on Day 22 (±3 days), and every 8 weeks (±1 week) thereafter.
Measured: 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)
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).
Measured: up to 12 months post last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start11 Apr 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Why it stopped: Study was terminated prematurely by the Sponsor for reasons not related to the safety of study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-ALLStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556757
- Sponsor's protocol ID
- ResQ111
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07556757
- Acronym / sponsor ID
- ResQ111
- Keywords
- B-Cell, Acute, Lymphoblastic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated prematurely by the Sponsor for reasons not related to the safety of study drug
- Enrolment
- 4 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 t-haNK Arm | Experimental | Drug: CD19 t-haNKIV infusion of CD19 t-haNK |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 12 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.
- Histologically or flow cytometry documented pre B-ALL.
- 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.
- Must be willing to undergo a lumbar puncture (LP) for CSF analysis and administration of IT chemotherapy.
Key exclusion criteria (22 listed)
- Participants with T-cell leukaemia and Burkitt's M3 leukaemia.
- Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).
- Inadequate organ function, evidenced by the following laboratory results:
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19 t-haNKIV infusion of CD19 t-haNK | Drug | CD19 t-haNK Arm |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Study was terminated prematurely by the Sponsor for reasons not related to the safety of study drug). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19 t-haNK in people with B-ALL and Leukemia, run by ImmunityBio, Inc. at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated prematurely by the Sponsor for reasons not related to the safety of study drug). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.