A Phase 1/2 Multicenter Study of KTE-X19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 108

Inclusion Criteria

1. Documentation of relapsed or refractory CLL; subjects must have received at least 2 prior lines of treatment, one of which must include a BTK inhibitor
2. An indication for treatment per IWCLL 2018 criteria and radiographically measurable disease (at least 1 lesion > 1.5cm in diameter)
3. Adequate hematologic function
4. Adequate renal, hepatic, cardiac and pulmonary function
5. Age 18 or older
6. ECOG performance status of 0 or 1
7. Females of childbearing potential must have a negative serum or urine pregnancy test
8. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy or BTKi (ibrutinib or acalabrutinib) at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

- A history of treatment including any of the following:
a. Prior CD19 directed therapy
b. Treatment with alemtuzumab within 6 months before enrollment
c. Prior allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 6 months prior to enrollment
d. Live vaccine administration within 4 weeks before enrollment
e. Systemic immunosuppression or systemic treatment for any autoimmune disease not related to CLL in the 2 years before enrollment
- Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index
- History of autoimmune disease resulting in end-organ injury unless attributable to CLL (eg, ITP, AIHA)
- Diagnosis of Richter’s transformation or a history of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, skin, cervix, bladder, breast), superficial bladder cancer, asymptomatic localized low grade prostate cancer for which watch-and-wait approach is standard of care, or any other cancer that has been in remission for > 3 years prior to enrollment
- History of severe hypersensitivity reaction attributed to aminoglycosides or any of the agents required for treatment in this study
- CNS disease
- History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before enrolment
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment
- Primary immunodeficiency
- Known infection with HIV; chronic active hepatitis B; active hepatitis C. A history of hepatitis B or C is permitted if the viral load is undetectable by quantitative PCR or a comparable testing method.
- Presence of active fungal, bacterial, viral infection or any infection requiring antimicrobial treatment for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical
Monitor
- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted
- Any medical condition likely to interfere with assessment of safety or efficacy of study treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials