Phase 1 Study Of KITE-753 in R/R B-Cell ALL
ConditionB-cell Acute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
The goal of this clinical research study is to find the recommended dose of KITE-753 in patients with relapsed/refractory B-cell ALL. The safety of KITE-753 will also be studied.
Eligibility criteria
Qualifiers
Patients ≥18 years of age with relapsed and/or refractory B-cell ALL after 1 or more lines of therapy with ≥5% and <75% bone marrow blasts at the time of consent
Blasts should be positive (≥1%) for either CD19 or CD20 as assessed by flow-cytometry or positive for either CD19 or CD20 by immunohistochemistry
Patients with Philadelphia chromosome-positive ALL are eligible if they are intolerant or have failed 2 lines of any TKI or one line of second-generation TKI
ECOG performance status ≤2
Disqualifiers
Patients who have received prior CAR T-cell therapy or other cell therapies
History of CTCAE grade 4 neurologic event or grade 4 CRS (Lee 2014 criteria) with prior CD19-directed therapy
Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management Note: Simple urinary tract infections and uncomplicated bacterial or viral upper respiratory tract infections are permitted if the participant is responding to active treatment and satisfies the criteria of being afebrile for 48 hours (i.e., temperature < 38°C).
Symptomatic CNS disease (i.e. cranial nerve palsies) at the time of enrollment. Patients could have prior history of CNS disease but no symptomatic CNS disease at the time of study enrollment.
Trial design
Treatments tested in this trial
- KITE-753
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Kite, A Gilead Company
Collaborator
Source ClinicalTrials.gov