KTE-X19 treatment for adult Japanese patients with certain blood cancers

A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

This study is testing a new treatment called KTE-X19 for adult Japanese patients with certain types of blood cancers to see if it can help them get better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gilead Sciences (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 9 sites (Chiba and 8 other locations)
• Trial ID: NCT06253663 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and effectiveness of KTE-X19 in adult Japanese participants suffering from relapsed or refractory Mantle Cell Lymphoma (MCL) and B-precursor Acute Lymphoblastic Leukemia (B-ALL). The primary objectives include assessing the objective response rate in MCL patients and overall complete remission in B-ALL patients. Participants will receive KTE-X19 along with Cyclophosphamide and Fludarabine, and those who complete the study will transition to a long-term follow-up phase for up to 15 years. The study aims to provide valuable insights into the treatment of these challenging hematological malignancies.

Who should consider this trial

Good fit: Ideal candidates are adult Japanese patients with relapsed or refractory Mantle Cell Lymphoma or B-precursor Acute Lymphoblastic Leukemia who meet specific eligibility criteria.

Not a fit: Patients with other types of leukemia or lymphoma not specified in the study may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Other studies have shown promising results with similar CAR T-cell therapies, indicating potential for success in this approach.

Eligibility criteria

Key Inclusion Criteria:

MCL Cohort:

* Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or presence of t(11;14)
* Up to 5 prior regimens for MCL. Prior therapy must have included:

  * Anthracycline-, bendamustine-, or high-dose cytarabine- containing chemotherapy, and
  * Anti-CD20 monoclonal antibody therapy, and
  * Bruton's tyrosine kinase inhibitor (BTKi)
* Relapsed or refractory disease, defined by the following:

  * Disease progression after last regimen, or
  * Refractory disease is defined failure to achieve partial response (PR) or complete remission (CR) to the last regimen
* At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy

  * If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 2 cm

ALL Cohort:

* Relapsed or refractory B-ALL defined as one of the following:

  * Relapsed or refractory disease after one line of systemic therapy;

    * Primary refractory, or
    * First relapse if first remission ≤ 12 months
  * Relapsed or refractory disease after two or more lines of systemic therapy
  * Relapsed or refractory disease after allogeneic transplant provided individuals is at least 100 days from SCT at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
* Morphological disease in the bone marrow (\> 5% blasts)
* Individuals with Philadelphia-positive (Ph+) disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs

Key Exclusion Criteria:

MCL Cohort:

* History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease-free for at least 3 years
* Autologous SCT (autoSCT) within 6 weeks of planned KTE-X19 infusion
* History of alloSCT with the exception of individuals with no donor cells detected on chimerism \> 100 days after alloSCT
* Prior CD19 targeted therapy
* Prior CAR therapy or other genetically modified T-cell therapy
* History of hypersensitivity to any of the ingredients of KTE-X19 or to any of the animal-derived ingredients (bovine and rodent) used in the manufacturing process of KTE-X19

ALL Cohort:

* Diagnosis of Burkitt's leukemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis
* History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years
* History of hypersensitivity to any of the ingredients of KTE-X19 or to any of the animal-derived ingredients (bovine and rodent) used in the manufacturing process of KTE-X19

Note: Other protocols defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Chiba and 8 other locations

• Chiba University Hospital — Chiba, Japan (Recruiting)
• Kyushu University Hospital — Fukuoka, Japan (Recruiting)
• Hokkaido University Hospital — Hokkaido, Japan (Recruiting)
• Kyoto University Hospital — Kyoto, Japan (Recruiting)
• Tohoku University Hospital — Miyagi, Japan (Recruiting)
• Okayama University Hospital — Okayama, Japan (Recruiting)
• National Cancer Center Hospital — Tokyo, Japan (Recruiting)
• Juntendo University Hospital — Tokyo, Japan (Recruiting)
• Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Medical Information

Conditions Relapsed/Refractory Mantle Cell Lymphoma; Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia