Trial Title:
Multi-antigen Specific CD8+ T Cells with Decitabine and Lymphodepleting Chemotherapy for the Treatment of Patients with Relapsed or Refractory AML or MDS Following an Allogeneic Hematopoietic Cell Transplantation from a Matched Donor
NCT ID:
NCT06572631
Condition:
Recurrent Acute Myeloid Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Refractory Myelodysplastic Syndrome
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Recurrence
Cyclophosphamide
Fludarabine
Decitabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Allogeneic CD8+ Leukemia-associated Antigens Specific T Cells NEXI-001
Description:
Given IV
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
NEXI 001
Other name:
NEXI-001
Other name:
NEXI001
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Aspiration
Description:
Undergo bone marrow aspiration
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Intervention type:
Procedure
Intervention name:
Bone Marrow Biopsy
Description:
Undergo bone marrow biopsy
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
Biopsy of Bone Marrow
Other name:
Biopsy, Bone Marrow
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Given IV
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
(-)-Cyclophosphamide
Other name:
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Other name:
Asta B 518
Other name:
B 518
Other name:
B-518
Other name:
B518
Other name:
Carloxan
Other name:
Ciclofosfamida
Other name:
Ciclofosfamide
Other name:
Cicloxal
Other name:
Clafen
Other name:
Claphene
Other name:
CP monohydrate
Other name:
CTX
Other name:
CYCLO-cell
Other name:
Cycloblastin
Other name:
Cycloblastine
Other name:
Cyclophospham
Other name:
Cyclophosphamid monohydrate
Other name:
Cyclophosphamide Monohydrate
Other name:
Cyclophosphamidum
Other name:
Cyclophosphan
Other name:
Cyclophosphane
Other name:
Cyclophosphanum
Other name:
Cyclostin
Other name:
Cyclostine
Other name:
Cytophosphan
Other name:
Cytophosphane
Other name:
Cytoxan
Other name:
Fosfaseron
Other name:
Genoxal
Other name:
Genuxal
Other name:
Ledoxina
Other name:
Mitoxan
Other name:
Neosar
Other name:
Revimmune
Other name:
Syklofosfamid
Other name:
WR 138719
Other name:
WR- 138719
Other name:
WR-138719
Other name:
WR138719
Intervention type:
Drug
Intervention name:
Decitabine
Description:
Given IV
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
5-Aza-2'-deoxycytidine
Other name:
Dacogen
Other name:
Decitabine for Injection
Other name:
Deoxyazacytidine
Other name:
Dezocitidine
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
EC
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Given IV
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
Fluradosa
Intervention type:
Procedure
Intervention name:
Leukapheresis
Description:
Undergo leukapheresis
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
Leukocytopheresis
Other name:
Therapeutic Leukopheresis
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (NEXI-001, decitabine, chemotherapy)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Summary:
This phase I trial tests the safety, side effects and best dose of NEXI-001 when given
with decitabine and lymphodepleting chemotherapy in treating patients with acute myeloid
leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of
improvement (relapsed) or that has not responded to previous treatment (refractory)
following an allogeneic hematopoietic cell transplantation from a matched donor. NEXI-001
is a type of chimeric antigen receptor T cell therapy in which a patient's T cells (a
type of immune system cell) are changed in the laboratory so they will attack cancer
cells. T cells are taken from a patient's blood. Then the gene for a special receptor
that binds to a certain protein on the patient's cancer cells is added to the T cells in
the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large
numbers of the CAR T cells are grown in the laboratory and given to the patient by
infusion for treatment of certain cancers. Decitabine is in a class of medications called
hypomethylation agents. It works by helping the bone marrow produce normal blood cells
and by killing abnormal cells in the bone marrow. Lymphodepleting chemotherapy, with
fludarabine and cyclophosphamide, helps kill cancer cells in the body and helps prepare
the body for the new CAR-T cells. Giving NEXI-001 with decitabine and lymphodepleting
chemotherapy may be safe and tolerable in treating patients with relapsed or refractory
AML or MDS following an allogeneic hematopoietic cell transplantation from a matched
donor.
Detailed description:
PRIMARY OBJECTIVES:
I. Characterize the safety of allogeneic CD8+ leukemia-associated antigens specific T
cells NEXI-001 (NEXI-001) combined with decitabine.
II. Determine the recommended phase 2 dose (RP2D) for NEXI-001 T cells combined with
decitabine.
SECONDARY OBJECTIVES:
I. Investigate the preliminary anti-leukemic activity of NEXI-001 T cells combined with
decitabine based on:
Ia. Complete response (CR) rate; Ib. Overall response rate (ORR); Ic. Median duration of
response; Id. 1-year overall survival (OS); Ie. 1-year progression-free survival (PFS).
II. Cumulative incidence of acute graft-versus-host disease (aGVHD) of grades 2-4 and 3-4
at day 100 post first infusion of NEXI-001.
III. Cumulative incidence of chronic graft-versus-host disease (cGVHD) of all grades at 1
year post first infusion of NEXI-001.
IV. Characterize the T cells in the NEXI-001 product by immunophenotype and tumor antigen
specificity.
V. Characterize NEXI-001 T cells in peripheral blood (PB) and bone marrow (BM) by
immunophenotype and tumor antigen specificity.
VI. Expansion and persistence of NEXI-001 T cells in PB and BM.
EXPLORATORY OBJECTIVES:
I. Evaluate the effect of the following factors on the safety and efficacy of NEXI-001 T
cells combined with decitabine:
Ia. NEXI-001 T-cell immunophenotype; Ib. Persistence of NEXI-001 T cells in PB and BM;
Ic. Blood levels of the antigen-specific NEXI-001 T cells; Id. Biomarkers of activation,
proliferation, and exhaustion of T cells; Ie. The expression of tumor associated antigen
(TAAs) and checkpoint molecules on AML blasts.
OUTLINE: This is a dose-escalation study of decitabine in combination with NEXI-001,
fludarabine and cyclophosphamide.
DONOR: Donors undergo leukapheresis on study.
PATIENTS: Patients may receive bridging therapy per standard of care ≥ 14 days prior to
the start of cycle 1. Patients receive decitabine intravenously (IV) over 1 hour once per
day (QD) on day -3, -5 or -10 to day -1, lymphodepletion chemotherapy with fludarabine IV
over 30 minutes QD and cyclophosphamide IV over 60 minutes QD on day -5 to -3 and then
receive NEXI-001 IV over 30 minutes QD on days 1, 8 and 15 of cycle 1. Cycles repeat
every 33 or 38 days in the absence of disease progression or unacceptable toxicity. If
NEXI-001 cells remain and treatment criteria are met, patients may receive and additional
cycle of decitabine IV over 1 hour QD on day -5 to -1 and NEXI-001 IV QD on days 1, 8 and
15 in the absence of disease progression or unacceptable toxicity. Patients undergo
echocardiography (ECHO) during screening, bone marrow aspirate and/or bone marrow biopsy,
positron emission tomography (PET)/computed tomography (CT) scan or magnetic resonance
imaging (MRI) and blood sample collection throughout the study.
After completion of study treatment, patients are followed up within 30 days and every 3
months for up to 1 year.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- PARTICIPANT: Documented informed consent of the participant and/or legally
authorized representative and documented informed consent of the donor
- PARTICIPANT: Agreement to allow the use of archival tissue from diagnostic tumor
biopsies (if unavailable, exceptions may be granted with study principal
investigator [PI] approval)
- PARTICIPANT: Age: ≥ 18 years
- PARTICIPANT: Eastern Cooperative Oncology Group (ECOG) ≤ 1 or Karnofsky performance
score (KPS) ≥ 70
- PARTICIPANT: Confirmed diagnosis of AML/MDS that has relapsed after or is refractory
to an allogeneic hematopoietic cell transplantation (HCT) from a matched donor.
- Refractory - failure to achieve a complete response minimal residual disease
(CRMRD) (-) by multicolor flow cytometry (MFC) or reverse transcription
polymerase chain reaction (RT qPCR)
- Relapse - detection of clonal abnormal myeloid blasts by morphology
(morphologic relapse) or by MFC, or RT-qPCR analysis (MRD[+] relapse) after
achieving a CRMRD(-) induced by an allogeneic HCT or maintained by allogeneic
HCT administered as consolidation therapy.
Note: Patients who meet the protocol definition of relapse/refractory (r/r) AML/MDS at
screening and subsequently achieve a CRMRD(-) response status following
protocol-specified bridging therapy will remain eligible to continue participation in
this study
- PARTICIPANT: At least 100 days post allogeneic HCT
- PARTICIPANT: Donor match at 8 out of 8 loci for human leucocyte antigen (HLA) -A,
-B, -C, and -DRB1 (each typed at high resolution by deoxyribonucleic acid
[DNA]-based methods)
- PARTICIPANT: Expression of HLA-A*0201 as determined by high resolution
sequence-based typing methods
- PARTICIPANT: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has
Gilbert's disease) (to be performed within 28 days of consenting)
- PARTICIPANT: Aspartate aminotransferase (AST) ≤ 2.5 x ULN (to be performed within 28
days of consenting)
- PARTICIPANT: Alanine aminotransferase (ALT) ≤ 2.5 x ULN (to be performed within 28
days of consenting)
- PARTICIPANT: Serum creatinine < 1.5 mg/dL or creatinine clearance of ≥ 60 mL/min per
24 hour urine test or the Cockcroft-Gault formula (to be performed within 28 days of
consenting)
- PARTICIPANT: Left ventricular ejection fraction (LVEF) ≥ 50% Note: To be performed
before the first dose of lymphodepletion chemotherapy
- PARTICIPANT: If able to perform pulmonary function tests: Forced expiratory volume
in one second (FEV1), forced vital capacity (FVC), and diffuse lung capacity for
carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for
hemoglobin) (to be performed within 28 days of consenting)
- PARTICIPANT: If unable to perform pulmonary function tests: Oxygen (O2) saturation >
92% on room air (to be performed within 28 days of consenting)
- PARTICIPANT: Seronegative for HIV antigen/antibody (Ag/Ab) combo, hepatitis C virus
(HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis
(rapid plasma reagin [RPR]) (to be performed within 28 days of consenting)
- If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed.
OR
- If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be
performed. Viral load must be undetectable
- PARTICIPANT: Women of childbearing potential (WOCBP): Negative urine or serum
pregnancy test. If the urine test is positive or cannot be confirmed as negative, a
serum pregnancy test will be required (to be performed within 28 days of consenting)
- PARTICIPANT: Agreement by females and males of childbearing potential to use an
effective method of birth control or abstain from heterosexual activity for the
course of the study through at least 3 months after the completion of the last cycle
of protocol therapy.
- Childbearing potential defined as not being surgically sterilized (men and
women) or have not been free from menses for > 1 year (women only)
- DONOR: The identified donor must be the donor whose stem cells were used for the
research participant's allo HCT
- DONOR: The donor's hematocrit value is ≥ 35%
- DONOR: The donor's platelet count is > 100,000 per microliter
- CRITERIA TO PROCEED TO START OF CYCLE 1: NEXI-001 product is released from
manufacturing with a certificate of analysis (COA)
- CRITERIA TO PROCEED TO START OF CYCLE 1: Bone marrow aspirate and bone marrow biopsy
within one week prior to treatment for baseline disease status (all disease statuses
are eligible to proceed) and correlative studies
- CRITERIA TO PROCEED TO START OF CYCLE 1: T-cell chimerism ≥ 50% to donor by
polymerase chain reaction (PCR) analysis
- CRITERIA TO PROCEED TO START OF CYCLE 1: Fully recovered to ≤ grade 1 from
non-hematologic acute toxic effects (except alopecia) from prior anti-cancer therapy
- CRITERIA TO PROCEED TO START OF CYCLE 1: Total bilirubin ≤ 1.5 X ULN (unless has
Gilbert's disease) (to be performed within 2 days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: AST =< 2.5 x ULN (to be performed within 2
days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: ALT =< 2.5 x ULN (to be performed within 2
days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: Serum creatinine < 1.5 mg/dL or creatinine
clearance of ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (to
be performed within 2 days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: If not receiving anticoagulants:
International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN. If on
anticoagulant therapy: PT must be within therapeutic range of intended use of
anticoagulants (to be performed within 2 days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: If not receiving anticoagulants: Activated
partial thromboplastin Time (aPTT) ≤ 1.5 x ULN. If on anticoagulant therapy: aPTT
must be within therapeutic range of intended use of anticoagulants (to be performed
within 2 days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: Left ventricular ejection fraction (LVEF) ≥
50% (to be performed within 2 days prior to start of cycle therapy)
- Note: To be performed before the first dose of LD chemotherapy
- CRITERIA TO PROCEED TO START OF CYCLE 1: Corrected QT (QTc) ≤ 480 ms (to be
performed within 2 days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: O2 saturation > 92% on room air (to be
performed within 2 days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: Women of childbearing potential (WOCBP):
Negative urine or serum pregnancy test. If the urine test is positive or cannot be
confirmed as negative, a serum pregnancy test will be required (to be performed
within 2 days prior to start of cycle therapy)
- CRITERIA TO PROCEED TO START OF CYCLE 1: Investigational drugs or devices within 30
days prior to start of cycle 1 therapy
- NEXI-001 INCLUSION CRITERIA: Total bilirubin ≤ 2.5 X ULN (unless has Gilbert's
disease) (to be performed within 1 days prior to NEXI-001 infusion)
- NEXI-001 INCLUSION CRITERIA: AST =< 3 x ULN (to be performed within 1 days prior to
NEXI-001 infusion)
- NEXI-001 INCLUSION CRITERIA: Serum creatinine < 2 mg/dL (to be performed within 1
days prior to NEXI-001 infusion)
- NEXI-001 INCLUSION CRITERIA: O2 saturation > 92% on room air (to be performed within
1 days prior to NEXI-001 infusion)
- CRITERIA TO PROCEED TO CYCLE 2: Patient has achieved a response of at least stable
disease
- CRITERIA TO PROCEED TO CYCLE 2: ANC must be at least 1,000/uL and platelets at least
50,000/uL to begin decitabine
- CRITERIA TO PROCEED TO CYCLE 2: Patient has not experienced a ≥ grade 3
NEXI-001-related nonhematological AE that did not resolve to ≤ grade 2 within 72
hours
Exclusion Criteria:
- PARTICIPANT: Patients who have had 2 prior allogeneic (allo) HCTs
- PARTICIPANT: Patients who have received more than 3 anti-leukemic treatments
regimens since their allo HCT
- PARTICIPANT: Vaccination with a live virus within six months prior to study
treatment.
- Inactivated influenza vaccination is allowed
- PARTICIPANT: Active acute or chronic GVHD
- PARTICIPANT: Known hypersensitivity to any component of the NEXI-001 T-cell product
or fludarabine, cyclophosphamide, decitabine, or tocilizumab
- PARTICIPANT: Clinically significant uncontrolled illness
- PARTICIPANT: A second primary malignancy that has not been in remission for > 2
years. Exceptions include the following resected lesions:
- Non-melanoma skin cancer.
- Carcinoma in situ.
- Squamous intraepithelial lesions on Pap smear.
- Localized prostate cancer (Gleason score < 6).
- Melanoma in situ
- PARTICIPANT: Females only: Pregnant or breastfeeding
- PARTICIPANT: Clinically significant cardiovascular disease:
- Myocardial infarction or unstable angina within 6 months prior to the start of
lymphodepleting (LD) chemotherapy.
- Cerebral vascular accident or a transient ischemic attack within 6 months prior
to the start of LD chemotherapy.
- Clinically significant cardiac arrhythmia
- Uncontrolled hypertension
- Congestive heart failure (New York Heart Association Class III or IV)
- Pericarditis or clinically significant pericardial effusion
- Myocarditis
- PARTICIPANT: History of autoimmune disease resulting in end organ injury or
requiring systemic immunosuppression or systemic disease modifying therapy within 2
years prior to enrollment.
- Patients with a history of autoimmune-related hypothyroidism on a stable dose
of thyroid replacement hormone remain eligible.
- Patients with controlled type 1 diabetes mellitus on a stable insulin regimen
remain eligible
- PARTICIPANT: Major trauma or major surgery within 4 weeks of enrollment
- PARTICIPANT: Dementia or altered mental status that precludes understanding the
informed consent form
- PARTICIPANT: History of seizures or other chronic clinically significant neurologic
disorders.
- Patients with well-controlled seizures on anti-seizure medication without a
seizure episode for ≥ 6 months remain eligible
- PARTICIPANT: Any other condition that would, in the Investigator's judgment,
contraindicate the patient's participation in the clinical study due to safety
concerns with clinical study procedures
- PARTICIPANT: Prospective participants who, in the opinion of the investigator, may
not be able to comply with all study procedures (including compliance issues related
to feasibility/logistics)
- DONOR: The donor is pregnant or breastfeeding at the time of requested donation
- DONOR: The donor had granulocyte colony stimulating factor (G-CSF) administered
within one month, prior to leukapheresis
- DONOR: The donor has an active bacterial or fungal infection, which is currently not
responding to antimicrobial treatment
- CRITERIA TO PROCEED TO START OF CYCLE 1: Other anti-leukemic (bridging) therapies
within 14 days of start of cycle 1 therapy
- CRITERIA TO PROCEED TO START OF CYCLE 1: Patients receiving systemic corticosteroid
(> 20 mg/day prednisone equivalent) or any other immunosuppressant agents at the
time of initiation of LD chemotherapy. Intermittent topical, inhaled, or intranasal
corticosteroids are allowed
- CRITERIA TO PROCEED TO START OF CYCLE 1: Active acute or chronic GVHD (Note: must
have resolved by the time of initiation of cycle 1 of therapy
- CRITERIA TO PROCEED TO START OF CYCLE 1: Active or uncontrolled infection requiring
antibiotics by the time LD chemotherapy is scheduled. Prophylactic and ongoing
therapy for prior controlled infection is allowed
- CRITERIA TO PROCEED TO START OF CYCLE 1: Females only: Pregnant or breastfeeding
- CRITERIA TO PROCEED TO START OF CYCLE 1: Clinically significant cardiovascular
disease:
- Myocardial infarction or unstable angina within 6 months prior to the start of
LD chemotherapy
- Cerebral vascular accident or a transient ischemic attack within 6 months prior
to the start of LD chemotherapy
- Clinically significant cardiac arrhythmia
- Uncontrolled hypertension
- Congestive heart failure (New York Heart Association Class III or IV)
- Pericarditis or clinically significant pericardial effusion
- Myocarditis
- History of seizures or other chronic clinically significant neurologic
disorders. Patients with well-controlled seizures on anti-seizure medication
without a seizure episode for ≥ 6 months remain eligible
- CRITERIA TO PROCEED TO START OF CYCLE 1: Any other condition that would, in the
Investigator's judgment, contraindicate the patient's participation in the clinical
study due to safety concerns with clinical study procedures
- NEXI-001 EXCLUSION CRITERIA: Patient has no evidence of NEXI-001-related
nonhematological adverse events (AEs), e.g. cytokine release syndrome (CRS), immune
effector cell-associated neurotoxicity syndrome (ICANS), hemophagocytic
lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS)
- NEXI-001 EXCLUSION CRITERIA: Patient has not developed any of the exclusion criteria
for treatment
- CRITERIA TO PROCEED TO CYCLE 2: Patient has not developed any of the exclusion
criteria for treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Contact:
Last name:
Monzr M. Al Malki
Phone:
626-218-2405
Email:
malmalki@coh.org
Contact backup:
Last name:
Monzr M. Al Malki
Start date:
December 7, 2024
Completion date:
December 12, 2026
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572631
