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Personalized NK Cell Therapy After Chemotherapy and Cord Blood Transplant

This study is testing a personalized natural killer (NK) cell therapy after chemotherapy and umbilical cord blood transplant for people with certain blood cancers, including acute myeloid leukemia (AML) and acute lymphoblastic leukemia. Researchers want to see how well this personalized NK cell therapy works. The therapy involves giving you natural killer cells (a type of immune cell that can fight cancer) along with chemotherapy drugs like Busulfan, Clofarabine, and Cyclophosphamide, and Anti-Thymocyte Globulin. The study will measure how long people live without their cancer getting worse (progression-free survival) for up to four years. This study is currently recruiting people aged 15 to 80 years old who have specific types of leukemia or other blood cancers.

Study design
This is a Phase II interventional study planning to enroll 100 participants. It is testing different chemotherapy regimens followed by a cord blood transplant and NK cell infusion.
What's involved
You would receive anti-thymocyte globulin, various chemotherapy drugs, and an umbilical cord blood transplant, followed by an infusion of NK cells between 30 and 180 days after the transplant.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be assessed for up to 4 years after your cord blood transplant or engraftment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02727803

Personalized NK Cell Therapy in CBT

Recruiting
PHASE2Ages 15–80InterventionalTreatment
M.D. Anderson Cancer Center
~100 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Allogeneic Natural Killer Cell Line NK-92Anti-Thymocyte GlobulinBusulfanClofarabineCyclophosphamideFludarabine Phosphate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) time in C2C2 patients
Measured over From the date of engraftment to disease progression or death, assessed up to 4 years
+1 more outcome measured

Conditions

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Biphenotypic Leukemia
Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia in Remission
Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Acute Myeloid Leukemia With Variant MLL Translocations
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chemotherapy-Related Leukemia
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
ISS Stage II Plasma Cell Myeloma
ISS Stage III Plasma Cell Myeloma
Myelodysplastic Syndrome
Myelodysplastic Syndrome With Excess Blasts
Myelodysplastic Syndrome With Gene Mutation
Myelodysplastic/Myeloproliferative Neoplasm
Previously Treated Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Hodgkin Lymphoma
Recurrent Non-Hodgkin Lymphoma
Refractory Acute Lymphoblastic Leukemia
Refractory Adult Acute Lymphoblastic Leukemia
Secondary Acute Myeloid Leukemia
Therapy-Related Myelodysplastic Syndrome

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveHematologic NeoplasmHodgkin's GranulomaMultiple MyelomaMyelodysplastic SyndromeNon-Hodgkin LymphomaSmall Lymphocytic LymphomaBCR/ABL1 Fusion GeneReceptor-Type Tyrosine-Protein Kinase FLT3

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Warren Fingrut, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Warren B Fingrut, MD
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \[abn\]\[3q\], -5/5q-, -7/7q-, abn\[12p\], abn\[17p\], myeloid/lymphoid or mixed-lineage leukemia \[MLL\] gene re-arrangement and t \[6;9\]47, fms related tyrosine kinase 3 \[flt3\] mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or arising from myelodysplastic syndromes (MDS), any disease beyond first remission
Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS/myeloproliferative syndromes, 8) complex karyotype, abn(3g), -5/5g-, -7/7g-, abn(12p), abn(17p)
Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and/or evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible
Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy
Chronic myeloid leukemia (CML) second chronic phase or accelerated phase
Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease
Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment
A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure
Patient age criteria: age \>= 15 and =\< 45 years (myeloablative regimen 1; age \>= 15 and =\< 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \>= 15 and =\< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3
Performance score of at least 60% by Karnofsky
Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)
Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)
Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)
Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \[GFR\]) \> 40mL/min/1.73 m\^2
Serum glutamate pyruvate transaminase (SGPT)/bilirubin \< to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT/bilirubin \< to 4.0 x normal (nonmyeloablative regimen 2)
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months
Patients with options for treatment that are known to be curative are not eligible
Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)

Exclusion

Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing
Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \[CB\] transplantation is proposed), or psychiatric condition that would limit informed consent
Active central nervous system (CNS) disease in patient with history of CNS malignancy
Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor

What this trial measures

  • Progression free survival (PFS) time in C2C2 patientsFrom the date of engraftment to disease progression or death, assessed up to 4 years

    Distributions of time-to-event variables will be estimated using the method of Kaplan and Meier, and Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, human leukocyte antigen (HLA) match, cytomegalovirus (CMV) status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.

  • Progression free survival (PFS) time in C1 patientsFrom the date of cord blood transplant to disease progression or death, assessed up to 4 years

    Distributions of time-to-event variables will be estimated using the method of Kaplan and Meier, and Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, HLA match, CMV status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.