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TerminatedNCT05370040Updated Mar 11, 2025Results posted

THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines

A Phase 1/2 interventional study of AAHI-SC2 Vaccine and AAHI-SC3 Vaccine in COVID-19, sponsored by ImmunityBio, Inc.. Terminated at 1 site in South Africa. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by ImmunityBio, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Discontinued prior to enroll in Phase 2
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a phase 1/2 open-label study assessing the safety, reactogenicity, and immunogenicity of saRNA COVID-19 boost vaccines in participants that have been previously vaccinated against or previously infected with COVID-19.

02

Conditions studied

  • COVID-19

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

ImmunityBio, Inc. is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 17 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adults ≥ 18 years of age at time of enrollment.
  2. Vaccinated with an EUA or approved vaccine against COVID-19 ≥ 3 months prior to enrollment on study or infection with COVID-19 ≥ 3 months prior to enrollment on study.
  3. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
  4. Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
  5. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  6. Temperature \< 38°C.
  7. Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males. Female participants of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male participants must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), intrauterine devices (IUDs), oral contraceptives, injectable contraceptives, patches, implants and abstinence.
  8. HIV-positive participants must have been on anti-retroviral therapy for ≥ 4 weeks and have HIV-1 viral load \< 1,000 copies/mL at the time of enrollment.

Exclusion criteria

Exclusion Criteria:

  1. Serious adverse reaction to any vaccine, any unrelated medication or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past.
  2. Confirmed current COVID-19, previous SARS-CoV-2 infection in the last \< 3 months, or PCR positive for SARS-CoV-2 at screening.
  3. Vaccinated with an EAU-approved vaccine against COVID-19 in the last \< 3 months.
  4. Pregnant or breastfeeding women.
  5. Chronic lung disease (included COPD) as evidenced by one or more exacerbations requiring a course of steroids in the last year, or the requiring chronic low dose oral steroids to prevent exacerbations. Uncontrolled asthma, defined as requiring reliever inhaler (short-acting beta agonist or ipratromium bromide) more than twice a week is also excluded.
  6. Bone marrow or organ transplant recipient
  7. Extreme obesity (defined as BMI of 40 kg/m2 or higher).
  8. Chronic kidney disease requiring dialysis.
  9. History of liver disease.
  10. Any disease associated with acute fever, or any infection.
  11. Participants with acquired or hereditary immunodeficiencies other than well-controlled HIV are excluded from enrollment.
  12. Current diagnosis of active tuberculosis.
  13. History of hereditary, idiopathic or acquired angioedema.
  14. No spleen or functional asplenia.
  15. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, or immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
  16. According to the judgement of the investigator any medical, psychiatric, psychological, social, occupational or other conditions that could affect the participants ability to sign informed consent, provide safety assessment data or comply with the requirements of the study protocol.
  17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Phase 1 Cohort 1A

    AAHI-SC2 on Day 1 at dosage 25 μg IM

    Biological: AAHI-SC2 Vaccine

  • Experimental
    Phase 1 Cohort 1B

    AAHI-SC2 on Day 1 at dosage 50 μg IM

    Biological: AAHI-SC2 Vaccine

  • Experimental
    Phase 1 Cohort 1C

    AAHI-SC2 on Day 1 at dosage 70 μg IM

    Biological: AAHI-SC2 Vaccine

  • Experimental
    Phase 1 Cohort 2A

    AAHI-SC3 on Day 1 at dosage 25 μg IM

    Biological: AAHI-SC3 Vaccine

  • Experimental
    Phase 1 Cohort 2B

    AAHI-SC3 on Day 1 at dosage 50 μg IM

    Biological: AAHI-SC3 Vaccine

  • Experimental
    Phase 1 Cohort 2C

    AAHI-SC3 on Day 1 at dosage 85 μg IM

    Biological: AAHI-SC3 Vaccine

  • Placebo comparator
    Phase 2 Control arm

    EUA or approved vaccine on Day 1

    Biological: EUA or approved vaccine

  • Experimental
    Phase 2 Experimental arm 1

    AAHI-SC2 on Day 1 Dose TBD as determined in phase 1 study

    Biological: AAHI-SC2 Vaccine

  • Experimental
    Phase 2 Experimental arm 2

    AAHI-SC3 on Day 1 Dose TBD as determined in phase 1 study

    Biological: AAHI-SC3 Vaccine

  • Experimental
    Phase 2 Experimental arm 3

    AAHI-SC3 on Day 1 and 29 Dose TBD as determined in phase 1 study

    Biological: AAHI-SC3 Vaccine

Interventions

  • BiologicalAAHI-SC2 Vaccine

    AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine

  • BiologicalAAHI-SC3 Vaccine

    AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine

  • BiologicalEUA or approved vaccine

    Janssen or Pfizer vaccines (control arm)

06

What researchers measure

Primary outcomes

  1. Phase 1 Safety - Incidence of MAAEs Through 1 Week

    Incidence of medically-attended adverse events (MAAEs)

    Time frame: through 1 week post final vaccine administration

  2. Phase 1 Safety - Incidence of MAAEs Through 30 Days

    Incidence of MAAEs

    Time frame: through 30 days post final vaccine administration

  3. Phase 1 Safety - Incidence of MAAEs Through 6 Months

    Incidence of MAAEs

    Time frame: through 6 months post final vaccine administration

  4. Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs

    Incidence and severity of solicited local reactogenicity AEs

    Time frame: through 1 week after each vaccine dose

  5. Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs

    Incidence and severity of solicited systemic reactogenicity AEs

    Time frame: through 1 week after each vaccine dose

  6. Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week

    Incidence and severity of unsolicited AEs

    Time frame: through 1 week post final vaccine administration

  7. Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days

    Incidence and severity of unsolicited AEs

    Time frame: through 30 days post final vaccine administration

  8. Phase 1 Safety - Incidence of SAEs Through 1 Week

    Incidence of serious adverse events (SAEs)

    Time frame: through 1 week post final vaccine administration

  9. Phase 1 Safety - Incidence of SAEs Through 30 Days

    Incidence of SAEs

    Time frame: through 30 days post final vaccine administration

  10. Phase 1 Safety - Incidence of SAEs Through 6 Months

    Incidence of SAEs

    Time frame: through 6 months post final vaccine administration

07

Results

Posted May 1, 2024
Limitations and caveats
The study was terminated early. Only the safety data is provided. Only one adverse event table per AE category was presented to reduce data entry redundancy.

Participant flow

Participant flow — Overall Study
MilestonePhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Started101010101010
Completed1010910910
Not completed001010
Withdrew: Lost to follow-up001010

Outcome measures

PrimaryPhase 1 Safety - Incidence of MAAEs Through 1 Week

Incidence of medically-attended adverse events (MAAEs)

Time frame:
through 1 week post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of MAAEs Through 1 Week
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of MAAEs Through 1 Week121000
PrimaryPhase 1 Safety - Incidence of MAAEs Through 30 Days

Incidence of MAAEs

Time frame:
through 30 days post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of MAAEs Through 30 Days
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of MAAEs Through 30 Days222201
PrimaryPhase 1 Safety - Incidence of MAAEs Through 6 Months

Incidence of MAAEs

Time frame:
through 6 months post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of MAAEs Through 6 Months
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of MAAEs Through 6 Months532222
PrimaryPhase 1 Safety - Incidence of Solicited Local Reactogenicity AEs

Incidence and severity of solicited local reactogenicity AEs

Time frame:
through 1 week after each vaccine dose
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs999899
PrimaryPhase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs

Incidence and severity of solicited systemic reactogenicity AEs

Time frame:
through 1 week after each vaccine dose
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs91010899
PrimaryPhase 1 Safety - Incidence of Unsolicited AEs Through 1 Week

Incidence and severity of unsolicited AEs

Time frame:
through 1 week post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week411113
PrimaryPhase 1 Safety - Incidence of Unsolicited AEs Through 30 Days

Incidence and severity of unsolicited AEs

Time frame:
through 30 days post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days525457
PrimaryPhase 1 Safety - Incidence of SAEs Through 1 Week

Incidence of serious adverse events (SAEs)

Time frame:
through 1 week post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of SAEs Through 1 Week
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of SAEs Through 1 Week000000
PrimaryPhase 1 Safety - Incidence of SAEs Through 30 Days

Incidence of SAEs

Time frame:
through 30 days post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of SAEs Through 30 Days
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of SAEs Through 30 Days000100
PrimaryPhase 1 Safety - Incidence of SAEs Through 6 Months

Incidence of SAEs

Time frame:
through 6 months post final vaccine administration
Reported as:
Count of participants · Participants
Phase 1 Safety - Incidence of SAEs Through 6 Months
ParticipantsPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2C
Phase 1 Safety - Incidence of SAEs Through 6 Months000100

Adverse events

Collected over For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1 Cohort 1A0/10 (0%)0/10 (0%)0/10 (0%)
Phase 1 Cohort 1B0/10 (0%)0/10 (0%)0/10 (0%)
Phase 1 Cohort 1C0/10 (0%)0/10 (0%)0/10 (0%)
Phase 1 Cohort 2A0/10 (0%)1/10 (10%)0/10 (0%)
Phase 1 Cohort 2B0/10 (0%)0/10 (0%)0/10 (0%)
Phase 1 Cohort 2C0/10 (0%)0/10 (0%)0/10 (0%)
Group 1: Cohort 1A0/10 (0%)0/10 (0%)9/10 (90%)
Group 1: Cohort 1B0/10 (0%)0/10 (0%)9/10 (90%)
Group 1: Cohort 1C0/10 (0%)0/10 (0%)9/10 (90%)
Group 1: Cohort 2A0/10 (0%)0/10 (0%)8/10 (80%)
Group 1: Cohort 2B0/10 (0%)0/10 (0%)9/10 (90%)
Group 1: Cohort 2C0/10 (0%)0/10 (0%)9/10 (90%)
Group 2: Cohort 1A0/10 (0%)0/10 (0%)9/10 (90%)
Group 2: Cohort 1B0/10 (0%)0/10 (0%)10/10 (100%)
Group 2: Cohort 1C0/10 (0%)0/10 (0%)10/10 (100%)
Group 2: Cohort 2A0/10 (0%)0/10 (0%)8/10 (80%)
Group 2: Cohort 2B0/10 (0%)0/10 (0%)9/10 (90%)
Group 2: Cohort 2C0/10 (0%)0/10 (0%)9/10 (90%)
Group 3: Cohort 1A0/10 (0%)0/10 (0%)5/10 (50%)
Group 3: Cohort 1B0/10 (0%)0/10 (0%)2/10 (20%)
Group 3: Cohort 1C0/10 (0%)0/10 (0%)5/10 (50%)
Group 3: Cohort 2A0/10 (0%)0/10 (0%)4/10 (40%)
Group 3: Cohort 2B0/10 (0%)0/10 (0%)5/10 (50%)
Group 3: Cohort 2C0/10 (0%)0/10 (0%)7/10 (70%)
Group 4: Cohort 1A0/10 (0%)0/10 (0%)5/10 (50%)
Group 4: Cohort 1B0/10 (0%)0/10 (0%)3/10 (30%)
Group 4: Cohort 1C0/10 (0%)0/10 (0%)2/10 (20%)
Group 4: Cohort 2A0/10 (0%)0/10 (0%)2/10 (20%)
Group 4: Cohort 2B0/10 (0%)0/10 (0%)2/10 (20%)
Group 4: Cohort 2C0/10 (0%)0/10 (0%)2/10 (20%)
Most frequent serious events
Most frequent serious events
EventPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2CGroup 1: Cohort 1AGroup 1: Cohort 1BGroup 1: Cohort 1CGroup 1: Cohort 2AGroup 1: Cohort 2BGroup 1: Cohort 2CGroup 2: Cohort 1AGroup 2: Cohort 1BGroup 2: Cohort 1CGroup 2: Cohort 2AGroup 2: Cohort 2BGroup 2: Cohort 2CGroup 3: Cohort 1AGroup 3: Cohort 1BGroup 3: Cohort 1CGroup 3: Cohort 2AGroup 3: Cohort 2BGroup 3: Cohort 2CGroup 4: Cohort 1AGroup 4: Cohort 1BGroup 4: Cohort 1CGroup 4: Cohort 2AGroup 4: Cohort 2BGroup 4: Cohort 2C
Abscess limbInfections and infestations0/100/100/101/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/10
Most frequent other events
Showing 10 of 40
Most frequent other events
EventPhase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2CGroup 1: Cohort 1AGroup 1: Cohort 1BGroup 1: Cohort 1CGroup 1: Cohort 2AGroup 1: Cohort 2BGroup 1: Cohort 2CGroup 2: Cohort 1AGroup 2: Cohort 1BGroup 2: Cohort 1CGroup 2: Cohort 2AGroup 2: Cohort 2BGroup 2: Cohort 2CGroup 3: Cohort 1AGroup 3: Cohort 1BGroup 3: Cohort 1CGroup 3: Cohort 2AGroup 3: Cohort 2BGroup 3: Cohort 2CGroup 4: Cohort 1AGroup 4: Cohort 1BGroup 4: Cohort 1CGroup 4: Cohort 2AGroup 4: Cohort 2BGroup 4: Cohort 2C
HeadacheNervous system disorders0/100/100/100/100/100/100/100/100/100/100/100/107/1010/1010/106/108/107/101/100/101/101/100/100/101/100/101/101/100/100/10
Injection site painGeneral disorders0/100/100/100/100/100/108/109/108/107/109/109/100/100/100/100/100/100/100/100/100/100/100/100/100/102/100/100/100/100/10
MyalgiaMusculoskeletal and connective tissue disorders0/100/100/100/100/100/100/100/100/100/100/100/107/109/109/106/108/107/100/100/100/100/100/100/100/100/100/100/100/100/10
ArthralgiaMusculoskeletal and connective tissue disorders0/100/100/100/100/100/100/100/100/100/100/100/106/108/108/105/108/108/100/101/101/100/100/100/100/100/100/100/100/100/10
ChillsGeneral disorders0/100/100/100/100/100/100/100/100/100/100/100/107/105/105/102/107/106/100/100/100/100/100/100/100/100/100/100/100/100/10
Injection site reactionGeneral disorders0/100/100/100/100/100/106/103/104/103/104/102/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/10
Abdominal painGastrointestinal disorders0/100/100/100/100/100/100/100/100/100/100/100/106/105/104/104/106/105/100/100/100/100/101/100/100/100/100/100/100/100/10
Injection site pruritusGeneral disorders0/100/100/100/100/100/104/103/105/103/104/104/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/10
Injection site hypoaesthesiaGeneral disorders0/100/100/100/100/100/105/101/104/105/103/104/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/100/10
FatigueGeneral disorders0/100/100/100/100/100/100/100/100/100/100/100/104/104/105/103/105/104/100/100/100/100/100/100/100/100/100/100/100/100/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)Phase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2CTotal
Mean35.4 ± 12.5228.7 ± 7.5332.6 ± 9.0037.2 ± 7.1032.7 ± 11.4429.3 ± 7.4832.7 ± 9.51
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2CTotal
Female888561045
Male22254015
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2CTotal
Hispanic or Latino0000000
Not Hispanic or Latino10101010101060
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2CTotal
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American10101010101060
White0000000
More than one race0000000
Unknown or Not Reported0000000
Healthy adults vaccinated with an EUA or approved vaccine against COVID-19 ≥3 months prior to enroll
Healthy adults vaccinated with an EUA or approved vaccine against COVID-19 ≥3 months prior to enroll(Participants)Phase 1 Cohort 1APhase 1 Cohort 1BPhase 1 Cohort 1CPhase 1 Cohort 2APhase 1 Cohort 2BPhase 1 Cohort 2CTotal
Count of participants10101010101060
08

Study locations

1 site
  • Wits Vida
    Johannesburg, South Africa
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 27, 2022
  • Protocol and statistical analysis plan · Oct 27, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05370040
Lead sponsor
ImmunityBio, Inc.
Responsible party
Sponsor
First posted
May 11, 2022
Start date
May 5, 2022
Primary completion
Mar 11, 2024
Completion
Mar 11, 2024
Results posted
May 1, 2024
Last update
Mar 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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