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B-Cell Lymphoblastic LeukemiaPhase 2NCT06144606

Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

A Phase 2 study testing Tecartus in people with B-Cell Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute 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 is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tecartus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
26 Dec 2023to 29 Jul 2031
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be an adult 18 years of age or older.
  • Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia.
  • Treatment and full recovery from induction chemotherapy, with following exceptions:
  • Vincristine associated grade 1 peripheral neuropathy B. Steroid/asparaginase associated diabetes and/or hypertension C. Inotuzumab/chemotherapy associated cytopenias
  • Patients must be in a complete remission with Minimal Residual Disease (MRD) following an induction regimen. MRD is defined herein as a bone marrow biopsy with fewer than 5% lymphoblasts. Complete remission implies the resolution of any extramedullary and/or Central Nervous Syndrome (CNS)-2-3/parenchymal disease.
  • Be willing and able to provide written informed consent/assent for the trial.
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  • Able to adhere to the study visit schedule and other protocol requirements.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate renal, hepatic, pulmonary, cardiac function.
  • Adequate hematopoietic reserve.
  • Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female:
  • 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
  • Subjects of both genders of child-bearing potential must be willing to practice birth control from the time of consent through 6 months after the completion of KTE-X19 infusion.

Who cannot join

  • Diagnosis of L3 type Burkitt's lymphoma, Mixed-Lineage Leukemia (MLL) rearranged leukemia, biphenotypic leukemia, mixed phenotype acute leukemia, blast phase of chronic myeloid leukemia, or stem-cell leukemia.
  • Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severe Congestive Heart Failure (CHF).
  • Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.
  • History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema.
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  • Active CNS/leptomeningeal leukemia.
  • Severe comorbid conditions for which life expectancy would be <6 months.
  • Patients with active (uncontrolled, metastatic) second malignancies are excluded.
  • History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome.
  • Primary immunodeficiency or history of autoimmune disease (Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
  • Corticosteroid therapy at a pharmacologic dose (> 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment.
  • Presence of any indwelling line or drain (percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
  • Live vaccine ≤ 4 weeks prior to enrollment.
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.

Trial locations and contacts

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

Connor Tate contact

813-745-3783

ICETtrials@moffitt.org

United States1 site, 1 recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Bijal D. Shah, MD

    Rawan Faramand, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy

Being tested
Tecartus
Medical subject headings
Burkitt Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • TecartusDrug

    Also called Brexucabtagene autoleucel, KTE-X19

    Tecartus is a CD19 directed CAR T-cell therapy that utilizes CD28 costimulatory and CD3 zeta stimulatory domains. Tecartus is manufactured from purified autologous T-cells via retroviral transduction with a median time to product release of 13 days.

Study groups in NCT06144606
Study groupRoleWhat they receive
Autologous CAR T-cell immunotherapyExperimentalTecartus will be delivered at a target dose of 1x106 cells / kg. For those >100 kg, a flat dose of 1 x108 cells will be used. Tecartus will be administered on day 0, following 1 day of rest from conditioning chemotherapy.
Receives: Drug: Tecartus

What is being measured

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

  1. Relapse Free Survival (RFS)

    The primary endpoint is RFS, defined as the time from KTE-X19 infusion until clinical relapse or death from any cause. Patients proceeding to subsequent anti-cancer therapy, inclusive of allogeneic transplantation, without relapse will be censored in this analysis. Surviving patients not meeting criteria for relapse by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

    Measured: Up to 5 years

Secondary outcomes (8)

  1. Molecular Response Rate

    Measured as converting to a complete molecular remission following CAR T-cell immunotherapy. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.

    Measured: Up to 5 years

  2. Clinical Relapse Rate

    Measured as >5% lymphoblasts in the bone marrow and/or the emergence of extramedullary leukemia.

    Measured: Up to 5 years

  3. Molecular Relapse Rate

    Measured as achieving complete molecular remission at day 28 and followed until 5 years from infusion or the emergence of detectable disease.

    Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.

    Measured: Up to 5 years

  4. Duration of Response (DOR)

    Measured as time from enrollment until clinical relapse or death. In the case of death without documented relapse, patients will be censored.

    Measured: Up to 5 years

  5. Molecular Relapse Free Survival (MRFS)

    Measured by complete molecular remission at day 28 and followed until 5 years from infusion or the emergence of detectable disease.

    Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.

    Measured: Up to 5 years

  6. Overall Survival

    Measured as time from date of enrollment to date of death from any cause.

    Measured: Up to 5 years

  7. Rate of Cytokine Release Syndrome (CRS)

    Participants rate of developing Cytokine Release Syndrome (CRS)

    Measured: Up to 5 years

  8. Rate of Immune effector cell-associated neurotoxicity syndrome (ICANS)

    Participants rate of developing Immune effector cell-associated neurotoxicity syndrome (ICANS).

    Measured: Up to 5 years

Timeline

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

  1. First posted22 Nov 2023
  2. Study start26 Dec 2023
  3. Primary completion29 Jul 2031 (estimated)
  4. Study completion29 Jul 2031 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06144606
Sponsor's protocol ID
MCC-22286
Status last verified
Sep 2026
First submitted
16 Nov 2023
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tecartus in people with B-Cell Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute 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 15 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 25 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Connor Tate (813-745-3783, ICETtrials@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse Free Survival (RFS) (time frame: Up to 5 years). 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 NCT06144606.

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 25 Sep 2026.

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