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B-cell Acute Lymphoblastic LeukemiaPhase 1NCT06559189

CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL

A Phase 1 study testing CD19x22 CAR T in people with B-cell Acute Lymphoblastic Leukemia, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL. Read more about this study

Who is it for?
Ages 3 months to 30 years
Conditions the study is for
B-cell Acute Lymphoblastic Leukemia
What is being tested?
CD19x22 CAR T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
27 Sep 2024to Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 3 months to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Subjects must have a history of B precursor ALL with any of the following conditions:
  • Relapsed two or more times.
  • Relapsed at any time after allogeneic bone marrow transplant (BMT).
  • Relapse or refractory after single antigen targeting CAR T cell therapy.
  • 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and/or parents declining BMT options and would prefer CAR T Therapy.
  • CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
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  • Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).
  • Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.
  • Males OR non-pregnant, non-lactating females.
  • Aged 3 months to 30 years (inclusive) at time of consent and enrollment.
  • Provision of a signed and dated consent form from parent or guardian (patients < 18), the patient themselves (> 18), or legally authorized representative (patient > 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed.
  • Stated willingness to comply with all study procedures and be available for the duration of the study.
  • Willingness to participate in long-term follow-up protocol.

Who cannot join

  • Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion.
  • History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
  • Less than 100 days post-transplant;
  • Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
  • Less than 6 weeks post donor lymphocyte infusion (DLI).
  • Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or increased risk of cytokine release syndrome.
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  • Evidence of severe organ dysfunction defined by:
  • Baseline oxygen saturation of < 90% on room air
  • Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings
  • Transaminases > 10x upper limit of normal (ULN) or bilirubin > 5x the ULN, unless thought to be related to primary disease
  • Estimated Creatinine (Cr) clearance < 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
  • Subjects of childbearing or child-fathering potential that are not willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the investigational product
  • Known HIV infection or active Hepatitis B or Hepatitis C infection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vanessa Fabrizio, MD contact

720-777-6860

BMT@childrenscolorado.org

United States1 site, 1 recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Vanessa Fabrizio, MD, 720-777-6860, BMT@childrenscolorado.org

    Vanessa Fabrizio, MD, MS

    Recruiting

Other trials in United States

About this study

Official title: Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Pediatric Patients With Relapsed and/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.

Read the detailed description

This is an open-label Phase I trial consisting of 2 cohorts to determine the safety and tolerability of CD19x22 CAR T in Pediatric Patients with R/R B-ALL. This trial will include two parallel cohorts based on disease burden prior to lymphodepleting chemotherapy, Cohort 1: high disease burden cohort: defined as >=25% bone marrow lymphoblasts and/or non-CNS extramedullary disease, and Cohort 2: low disease burden cohort: defined as <25% bone marrow lymphoblasts and no non-CNS extramedullary disease. Dose escalation will proceed independently within each cohort using the Bayesian Optimal Interval (BOIN) design. This trial will enroll up to 53 patients with 21 patients in each cohort receiving treatment with lymphodepleting chemotherapy followed by CD19x22 CAR T cell infusion, with a total of up to 42 treated patients overall. Patients will be assessed for dose limiting toxicities (up to 28 days from infusion) to determine a maximum tolerated dose (MTD) and for preliminary efficacy through morphological remission rate and measurable residual disease (MRD) levels.

Being tested
CD19x22 CAR T
Keywords
Pediatric, Relapsed, Refractory, B-cell Acute Lymphoblastic Leukemia, Hematologic diseases
Medical subject headings
Burkitt Lymphoma, Recurrence, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19x22 CAR TBiological

    The investigational product is an autologous, genetically modified CD19xCD22 CAR T cell product produced by the Gates Biomanufacturing Facility.

Study groups in NCT06559189
Study groupRoleWhat they receive
High Disease Burden CohortExperimental≥25% bone marrow lymphoblasts and/or non-CNS extramedullary disease. Dose escalation will proceed independently within each cohort using the Bayesian Optimal Interval (BOIN)design. Dose begins at DL -1(1x10^5 cells/kg).
Receives: Biological: CD19x22 CAR T
Low Disease Burden CohortExperimental<25% bone marrow lymphoblasts and no non-CNS extramedullary disease. Dose escalation will proceed independently within each cohort using the Bayesian Optimal Interval (BOIN)design. Dose begins at DL1 (3x10^5 cells/kg).
Receives: Biological: CD19x22 CAR T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Measured by Dose Limiting Toxicities (DLTs)

    The safety of the administering this bispecific CD19/CD22-directed CAR T cell product will be measured by assessing the DLTs in each disease burden cohort in a Bayesian optimal interval (BOIN) design to determine the MTD

    Measured: Infusion date to 28 days post-infusion

Secondary outcomes (6)

  1. Overall Response Rate

    The efficacy of this bispecific CD19/CD22-directed CAR T cell product will be measured by evaluating the overall response rate in each disease burden stratum based on a morphologic disease assessment to measure bone marrow status at Day 28 post-infusion.

    Measured: 28 days post-infusion

  2. Minimal Residual Disease (MRD) Rate

    The efficacy of this bispecific CD19/CD22-directed CAR T cell product will be monitored in each disease burden stratum by measuring peripheral blood MRD by next generation sequencing

    Measured: Months 1, 2, 3, 6, 9, and 12

  3. Minimal Residual Disease (MRD) Rate

    The efficacy of this bispecific CD19/CD22-directed CAR T cell product will be monitored in each disease burden stratum by measuring bone marrow MRD by flow cytometry and/or next generation sequencing.

    Measured: Months 1, 3, 6, and 12

  4. CD19-Relapse

    Cumulative incidence of CD19-relapse as determined by immunophenotype of leukemic blasts for subjects in each disease burden stratum will be calcualted using standard techniques using all enrolled patients and compared to published literature both from pre- and post-licensing clinical trials and/or reports.

    Measured: 1 year

  5. Overall Survival

    1-year overall survival (OS) rate in subjects with relapsed/refractory B-ALL treated with this bispecific CD19/CD22-directed CAR T cell product, stratified by disease burden.

    Measured: 1 year

  6. Progression Free Survival

    1-year progression-free survival (PFS) rate in subjects with relapsed/refractory B-ALL treated with this bispecific CD19/CD22-directed CAR T cell product, stratified by disease burden.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start27 Sep 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559189
Sponsor's protocol ID
22-0998.cc
Other IDs
NCI-2024-06242
Status last verified
Nov 2025
First submitted
15 Aug 2024
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19x22 CAR T in people with B-cell Acute Lymphoblastic Leukemia, run by University of Colorado, Denver at 1 site in United States.

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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanessa Fabrizio, MD (720-777-6860, BMT@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Measured by Dose Limiting Toxicities (DLTs) (time frame: Infusion date to 28 days post-infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06559189.

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 28 Nov 2025.

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