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NCT07674823
Study Of KITE-753 in R/R B-Cell ALL
Conditions: B-cell Acute Lymphoblastic Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: M.D. Anderson Cancer Center
Location: UT MD Anderson Houston Texas
Summary
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
Inclusion Criteria:
* Patients ≥18 years of age with relapsed and/or refractory B-cell ALL after 1 or more lines of therapy with ≥5% and \50 ml/min, direct bilirubin ≤1.5 mg/dL, AST/ALT ≤5.0 x ULN (except in patients with leukemia involvement where up to 10 x ULN is allowed), left ventricular ejection fraction \>40%
* The effects of KITE-753 on the developing human fetus are unknown. For this reason and because chemotherapy used in this trial is known to be teratogenic, women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least 12 months after the last dose of study treatment. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
* Postmenopausal (no menses in greater than or equal to 12 consecutive months).
* History of hysterectomy or bilateral salpingo-oophorectomy.
* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
* History of bilateral tubal ligation or another surgical sterilization procedure.
* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after the last dose of study treatment.
* Ability to understand and willingness to sign a written informed consent document
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Exclusion Criteria:
* 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.
* Presence of CNS-3 disease (defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3) with or without neurological changes, and presence of CNS-2 disease (defined as detectable cerebrospinal blast cells in a sample of CSF with \5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Patients unable/unwilling to sign informed consent form
* Because no dosing or adverse event data are currently available on the use of KITE-753 in patients \
Source: ClinicalTrials.gov (NCT07674823). StuddyBuddy aggregates publicly available trial information.