Back to search results

Study of Tecartus for B-Cell Acute Lymphoblastic Leukemia with Minimal Residual Disease

This Phase 2 study is testing Tecartus, a CAR T-cell therapy, in adults aged 18 and older who have B-cell acute lymphoblastic leukemia (B-ALL). Participants must have CD19 positive B-ALL and be in remission but still have minimal residual disease (MRD), meaning a very small number of cancer cells remain. The study aims to see how well Tecartus works and if it is safe. Tecartus uses your own T-cells, which are a type of immune cell, to fight the cancer. Researchers will measure how long participants live without their cancer returning (Relapse Free Survival) for up to 5 years.

Study design
This is a Phase 2 interventional study, meaning all 60 planned participants will receive the study treatment. It is designed to evaluate the efficacy and safety of Tecartus.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure how long they live without their cancer returning.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06144606

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~60 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Tecartus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relapse Free Survival (RFS)
Measured over Up to 5 years

Conditions

B-Cell Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia

Explore related trials

B Acute Lymphoblastic LeukemiaCD19 Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Bijal D. Shah, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Connor Tate
[email protected]
813-745-3783
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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:
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.
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:
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.

Exclusion

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.
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.

What this trial measures

  • Relapse Free Survival (RFS)Up to 5 years

    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.