Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05487651
Other study ID # ATX-K502-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 1, 2022
Est. completion date December 2024

Study information

Verified date May 2023
Source Athenex, Inc.
Contact Dan Lang, MD, PhD
Phone 716-970-4187
Email dlang@athenex.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multi-center study to evaluate the safety of KUR-502 in subjects with refractory/relapsed B-cell NHL or leukemia (ALL or CLL).


Description:

KUR-502 will be manufactured from leukapheresis products from healthy donors. Subjects will be enrolled into 2 parallel cohorts (Cohort A [non-ALL] and Cohort B [ALL]). Each cohort will undergo dose escalation independently. Three (3) dose levels will be evaluated in the ANCHOR and ANCHOR2 studies combined (1×107/m2, 3×107/m2, 1×108/m2). Dose levels are defined based on the number of transduced KUR-502 cells. Body surface area (BSA) will be capped at 2.4 m2. Subjects will receive <1×104 allogeneic T cells/kg at any dose level. The MTD will be determined once dose escalation is completed, and all subjects are evaluable for DLT. If there is no DLT that determines an MTD, a maximum dose level will be declared. Dose escalation will stop when 6 subjects have been treated at the MTD or highest dose level.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 75 Years
Eligibility INCLUSION CRITERIA Subjects must meet all of the following criteria to be included in this study: 1. Signed written informed consent. 2. Diagnosis of CD19+ B-cell lymphoma or leukemia (ALL or CLL). - Subjects who previously received CD19-directed therapy must have biopsy or flow cytometry-confirmed CD19+ tumor following the CD19-directed therapy; may be performed by local laboratory. 3. The disease is: Cohort A (non-ALL subjects): - Relapsed or refractory after =2 lines of therapy, including a CD20 antibody, if an indolent lymphoma. - Relapsed or refractory after =2 lines of therapy, including ibrutinib and venetoclax, if CLL. - Relapsed or refractory after =2 lines of therapy, including a CD20 antibody and an anthracycline, and the subject is ineligible for autologous stem cell transplantation, if an aggressive or highly aggressive lymphoma. - Ineligibility for autologous stem cell transplantation includes non-responsive disease after salvage therapy and failure to mobilize stem cells for transplant. Cohort B (ALL subjects): - Relapsed or refractory after =2 lines of therapy. 4. Measurable disease by current criteria (Lugano criteria for lymphomas, IWG criteria for CLL, and detectable disease for ALL). 5. Age 3 to 75 years; subjects <18 years old will not be enrolled as the first subject on any dose level. 6. BSA =2.4 m2. 7. Bilirubin <2 times the upper limit of normal (ULN) (3 times if the subject has Gilbert syndrome). 8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <5 times ULN. 9. Estimated glomerular filtration rate (GFR) =50 mL/min. 10. Pulse oximetry =90% on room air. 11. Karnofsky or Lansky score =70. 12. Recovered from the acute toxic effects of all prior chemotherapy based on the enrolling physician's assessment (if some effects of chemotherapy are expected to last long term, for example, residual neuropathy, anemia, or alopecia, subject is eligible if meets other eligibility criteria). 13. Life expectancy >12 weeks. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: 1. Females who are breastfeeding or pregnant at Screening (as documented by a positive urine or serum pregnancy test; may be performed by local laboratory). 2. Females of childbearing potential who: - Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) through the Day 365 visit or for 30 days after study drug discontinuation. - Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexual activity through the Day 365 visit or for 30 days after study drug discontinuation. - Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive through the Day 365 visit or for 30 days after study drug discontinuation. 3. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception through the Day 365 visit or for 30 days after study drug discontinuation). No sperm donation is allowed through the Day 365 visit or for 30 days after study drug discontinuation. 4. Currently receiving any investigational agents or received any cellular therapies within the previous 6 weeks prior to the KUR-502 infusion. 5. History of Grade 2 to 4 GvHD. 6. History of hypersensitivity reactions to murine protein-containing products. 7. Active infection with human immunodeficiency virus (HIV) or human T cell lymphotropic virus (HTLV). 8. Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 9. Uncontrolled active bacterial, fungal, or other viral infection.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
KUR-502
KUR-502 (CD19.CAR-aNKT cells) consists of transduced allogeneic natural killer T cells (aNKT) genetically modified with additional features to enhance their anti-tumor activity against CD19+ B-cell malignancies. Following intravenous (IV) infusion, the product is expected to kill CD19+ tumor cells by direct interaction with the chimeric antigen receptor (CAR), and activation of the NKT cells to kill tumor through their innate cell killing.

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas
United States OHSU - Knight Cancer Center Portland Oregon
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Athenex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicity (DLT) rate and grade of single dose of Kur-502 Incidence rate and the grade (severity) of dose-limiting toxicities (DLTs) based on adverse events (AEs) reported according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) v5.0 4 weeks post T cell infusion
See also
  Status Clinical Trial Phase
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Withdrawn NCT05929716 - An Open-Label, Single Center Phase 2 Study of Magrolimab, Rituximab and Radiation as Bridging Strategy Before CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphoma Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Recruiting NCT05016947 - Venetoclax Plus Inotuzumab for B-ALL Phase 1
Completed NCT02900716 - Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas Phase 1
Completed NCT03068416 - CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy Phase 2
Not yet recruiting NCT05014100 - Orelabrutinib in Combination With R2 Regimen for R/R CD20+ B-cell Lymphoma Phase 2
Recruiting NCT05934838 - A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas Phase 1
Terminated NCT04023071 - FT516 in Subjects With Advanced Hematologic Malignancies Phase 1
Active, not recruiting NCT04148430 - A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy Phase 2
Completed NCT02933320 - BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia Phase 1/Phase 2
Active, not recruiting NCT03133221 - 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Phase 2
Completed NCT02741388 - A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP Phase 1
Completed NCT02300402 - Detection and Characterization of Residual Masses in Lymphomas
Terminated NCT02266147 - Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma Phase 1/Phase 2
Terminated NCT00906841 - Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma Phase 2
Completed NCT00338494 - Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma Phase 1
Withdrawn NCT05570188 - Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT03281551 - Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma Phase 1
Completed NCT03734601 - Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation Phase 2