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

NCT07556757 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ResQ111
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

B-ALL; Leukemia

Keywords

B-Cell; Acute; Lymphoblastic

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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)

  up to 12 months post last dose of study drug

Study Arms (1)

CD19 t-haNK Arm

EXPERIMENTAL

IV infusion of CD19 t-haNK

Drug: CD19 t-haNK

Interventions

CD19 t-haNK DRUG

IV infusion of CD19 t-haNK

CD19 t-haNK Arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (2)

Dr Jackie Thomson Inc

Johannesburg, 2193, South Africa

RECRUITING

Alberts Cellular Therapy

Pretoria, 0044, South Africa

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Kayleigh Russell

CONTACT

424-539-2412; kayleigh.russell@immunitybio.com

Mark Nelson

CONTACT

mark.nelson@immunitybio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: April 29, 2026
• Study Start: April 11, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)