B-cell Acute Lymphoblastic LeukemiaPhase 1NCT07674823
Study Of KITE-753 in R/R B-Cell ALL
A Phase 1 study testing KITE-753 in people with B-cell Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- KITE-753
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 1 Apr 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Adequate organ function: Creatinine clearance >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:
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- 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.
Who cannot join
- 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 WBCs per mm3) with neurological changes Note: Subjects with CNS-1 (no detectable leukemia in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study.
- History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia (grade 2 or higher memory impairment per CTCAEv5.0), Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade ≥3) CNS events including ICANS from T cell engager therapies.
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- Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment
- Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
- Current uncontrolled autoimmune disease
- History of Hemophagocytic lymphohistiocytosis / Macrophage activation syndrome
- Prior medication:
- Salvage systemic therapy (including chemotherapy, TKIs for Ph+ ALL, and blinatumomab) within 1 week or 5 half-lives (whichever is shorter) prior to enrollment
- Treatment with alemtuzumab within 6 months prior to enrollment, clofarabine or cladribine within 3 months prior to enrollment, or PEG-asparaginase within 3 weeks prior to enrollment
- Donor lymphocyte infusion (DLI) within 28 days prior to enrollment
- Any drug used for GVHD within 4 weeks prior to enrollment (e.g., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide), or immunosuppressive antibody used within 4 weeks prior to enrollment (e.g., antiCD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor)
- Corticosteroid therapy at a pharmacologic dose (>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 <18 years of age, children are excluded from this study
- Human Immunodeficiency Virus (HIV)-positive unless taking appropriate anti-HIV medications, having an undetectable viral load by qPCR, and a CD4 count ≥200 cells/µL
- Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants, secondary to treatment of the mother with KITE753, breastfeeding should be discontinued if the mother is treated with KITE-753
- WOCBP must have a negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patients of either sex who are not willing to practice highly effective birth control from the time of informed consent through 12 months after lymphodepleting chemotherapy or the KITE-753 administration, whichever is longer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Nitin Jain, MBBS, 713-745-6080, njain@mdanderson.org
Nitin Jain, MBBS
About this study
Official title: A Phase 1 Study Evaluating The Safety And Efficacy Of KITE-753, Autologous Anticd19/CD20 CAR T-Cell Therapies, In Patients With Relapsed And/Or Refractory B-Cell Acute Lymphoblastic Leukemia
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.
Read the detailed description
Primary Objective:
Evaluate the safety of KITE-753 and establish recommended phase 2 dose (RP2D) of KITE-753 in patients with relapsed/refractory B-cell ALL
Secondary Objectives:
- Evaluate overall response rate (ORR), defined as complete remission (CR) plus CR with incomplete blood count recovery (CRi) B. Assess duration of response (DOR), event-free survival (EFS) and overall survival (OS) C. Evaluate the number of patients achieving measurable residual disease (MRD)-negativity in the bone marrow (BM), as measured by ClonoSEQ NGS testing (sensitivity 10-6) and flow cytometry (sensitivity 10-4) D. Evaluate the rate of persistent NGS MRD negativity at 6 and 12 months
Exploratory Objectives:
- CAR-T-cell expansion (Days 7, 10, 14, 21, 28, then monthly up to 3 months then every 3 months up to 24 months post-infusion) B. B-cell aplasia (Day -5, Day 0, Day 28, monthly up to 3 months and then every 3 months up to 24 months post-infusion) C. MRD-negativity by NGS (at 10-6 sensitivity) (peripheral blood [PB] / BM: Day 14 (PB), Day 28 (PB and BM), and then every 3 months (PB and BM) up to 24 months post-infusion) D. Cytokine panel to study cytokine profile including IL1, IL2, IL6, IFN-gamma, TNF-alpha from infusion (Days 0, 3, 5, 7, 10, 14, 28) E. Additional correlatives samples may be collected at baseline, Day28 and every 3 months from infusion. These may include samples used for bulk RNA sequencing of the tumor and germline variants, single cell RNA sequencing of CAR T-cells and assessing the methylation signatures of the CAR T-cells.
Sample collection for Exploratory objectives A-E will be done as part of standard of care
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- KITE-753
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KITE-753Drug
Given by infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment with KITE-753 CAR T-Cells | Experimental | Participants will be hospitalized during the treatment period from Day -1 prior to KITE-753 administration until a minimum of 7 days after KITE-753 administration (Day 7).
Participants will remain in the hospital through day 7 post infusion of KITE-753 and not be discharged from the hospital until all CAR-T-related non-hematological toxicities return to grade ≤1 or return to baseline. Receives: Drug: KITE-753 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start31 Dec 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kite, A Gilead Company
- Responsible party
- Sponsor
- Investigators
- Nitin Jain, MBBS, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674823
- Sponsor's protocol ID
- 2026-0598
- Other IDs
- NCI-2026-04964
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating The Safety And Efficacy Of KITE-753, Autologous Anticd19/CD20 CAR T-Cell Therapies, In Patients With Relapsed And/Or Refractory B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07674823
- Acronym / sponsor ID
- 2026-0598
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Kite, A Gilead Company
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
Evaluate the safety of KITE-753 and establish recommended phase 2 dose (RP2D) of KITE-753 in patients with relapsed/refractory B-cell ALL
Secondary Objectives:
- Evaluate overall response rate (ORR), defined as complete remission (CR) plus CR with incomplete blood count recovery (CRi) B. Assess duration of response (DOR), event-free survival (EFS) and overall survival (OS) C. Evaluate the number of patients achieving measurable residual disease (MRD)-negativity in the bone marrow (BM), as measured by ClonoSEQ NGS testing (sensitivity 10-6) and flow cytometry (sensitivity 10-4) D. Evaluate the rate of persistent NGS MRD negativity at 6 and 12 months
Exploratory Objectives:
- CAR-T-cell expansion (Days 7, 10, 14, 21, 28, then monthly up to 3 months then every 3 months up to 24 months post-infusion) B. B-cell aplasia (Day -5, Day 0, Day 28, monthly up to 3 months and then every 3 months up to 24 months post-infusion) C. MRD-negativity by NGS (at 10-6 sensitivity) (peripheral blood [PB] / BM: Day 14 (PB), Day 28 (PB and BM), and then every 3 months (PB and BM) up to 24 months post-infusion) D. Cytokine panel to study cytokine profile including IL1, IL2, IL6, IFN-gamma, TNF-alpha from infusion (Days 0, 3, 5, 7, 10, 14, 28) E. Additional correlatives samples may be collected at baseline, Day28 and every 3 months from infusion. These may include samples used for bulk RNA sequencing of the tumor and germline variants, single cell RNA sequencing of CAR T-cells and assessing the methylation signatures of the CAR T-cells.
Sample collection for Exploratory objectives A-E will be done as part of standard of care
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with KITE-753 CAR T-Cells | Experimental | Drug: KITE-753Participants will be hospitalized during the treatment period from Day -1 prior to KITE-753 administration until a minimum of 7 days after KITE-753 administration (Day 7). Participants will remain in the hospital through day 7 post infusion of KITE-753 and not be discharged from the hospital until all CAR-T-related non-hematological toxicities return to grade ≤1 or return to baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Adequate organ function: Creatinine clearance >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%
Key exclusion criteria (23 listed)
- 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 WBCs per mm3) with neurological changes Note: Subjects with CNS-1 (no detectable leukemia in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KITE-753Given by infusion | Drug | Treatment with KITE-753 CAR T-Cells |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- UT MD Anderson WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitin Jain, MBBS principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KITE-753 in people with B-cell Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Jain, MBBS ((713) 745-6080, njain@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.