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CAR T-cell Therapy
NK Cells + Cyclophosphamide + Etoposide for Solid Tumors
Phase 1
Recruiting
Led By Demetrios Petropoulos
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the nk cell infusion
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of cord blood-derived expanded allogeneic natural killer cells, given with cyclophosphamide and etoposide, to treat children and young adults with solid tumors.
Who is the study for?
This trial is for children and young adults with relapsed or refractory solid tumors. Participants must have a certain level of physical function, measurable disease, adequate kidney and liver function, controlled pulmonary symptoms, and no severe treatment-related toxicities. They should not be pregnant, dependent on steroids, or have primary brain tumors or uncontrolled infections.
What is being tested?
The trial tests the safety and effectiveness of donor NK cells from cord blood combined with chemotherapy drugs cyclophosphamide and etoposide in treating solid tumors that are resistant to standard treatments. It aims to find the best dose while assessing how well these therapies work together.
What are the potential side effects?
Potential side effects may include immune reactions due to donor NK cells, as well as typical chemotherapy-related issues like nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts (neutropenia), liver toxicity, and potential damage to other organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after the nk cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the nk cell infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Maximum tolerated dose and/or recommended phase 2 dose of cord blood-derived expanded allogeneic natural killer (NK) cells following chemotherapy
Secondary study objectives
NK cell persistence, phenotype, and function
Overall survival (OS)
Response rate per immune-related therapy trials Response Evaluation Criteria in Solid Tumors (irRECIST)
+1 moreSide effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640100%
Anemia
100%
Neutrophil count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Lymphocyte count decreased
100%
Platelet count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Anorexia
59%
Hypotension
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
55%
Hypophosphatemia
50%
Headache
45%
Alanine aminotransferase increased
45%
Hypoalbuminemia
45%
Hypocalcemia
41%
Dizziness
41%
Hypokalemia
36%
Anxiety
36%
Hyponatremia
32%
Vomiting
32%
Hypertension
32%
Cough
32%
Chills
32%
Insomnia
32%
Investigations
32%
Febrile neutropenia
27%
Aspartate aminotransferase increased
27%
Alkaline phosphatase increased
27%
Pain
23%
Arthralgia
23%
Hiccups
23%
Dysphagia
23%
Esophagitis
23%
Hypomagnesemia
23%
Infections and infestations
18%
Hemorrhoids
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dehydration
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hypoxia
14%
Hypermagnesemia
14%
Bloating
14%
Dyspepsia
14%
Paresthesia
14%
Rectal pain
14%
Infusion related reaction
14%
Immune system disorders
14%
INR increased
14%
Pleural effusion
9%
Renal and urinary disorders
9%
Arthritis
9%
Blood bilirubin increased
9%
Back pain
9%
Hypernatremia
9%
Bone pain
9%
Creatinine increased
9%
Skin ulceration
9%
Cholesterol high
9%
Dry skin
9%
Dysgeusia
9%
Upper respiratory infection
9%
Sore throat
9%
Flushing
9%
Non-cardiac chest pain
9%
General disorders and administration site conditions
9%
Hyperuricemia
9%
Nasal congestion
9%
Papulopustular rash
5%
Hypercalcemia
5%
Skin hyperpigmentation
5%
Bladder infection
5%
Gastrointestinal pain
5%
Ear pain
5%
Eye disorders
5%
Nervous system disorders
5%
Thromboembolic event
5%
Urinary frequency
5%
Encephalopathy
5%
Lung
5%
Atrial fibrillation
5%
Epistaxis
5%
Urinary tract infection
5%
Tremor
5%
Atelectasis
5%
Rash acneiform
5%
Flatulence
5%
Respiratory failure
5%
Weight gain
5%
Acute kidney injury
5%
Gastroesophageal reflux disease
5%
Edema face
5%
Endocrine disorders
5%
Metabolism and nutrition disorders
5%
Mucosal infection
5%
Neck pain
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypoglycemia
5%
Musculoskeletal and connective tissue disorder
5%
Myalgia
5%
Hypothyroidism
5%
Lung infection
5%
Lymph node pain
5%
Lymphocyte count increased
5%
Pain in extremity
5%
Peripheral motor neuropathy
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Urinary tract pain
5%
Vascular disorders
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cyclophosphamide, etoposide, NK cells)Experimental Treatment3 Interventions
Patients receive cyclophosphamide IV QD over 30 minutes and etoposide IV QD over 60 minutes on days 1-5 in the absence of unacceptable toxicity. Patients then receive cord blood derived allogeneic NK cells IV on day 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natural Killer Cell
Not yet FDA approved
Cyclophosphamide
FDA approved
Beta-D-Glucose
Not yet FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,309 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,049 Total Patients Enrolled
Demetrios PetropoulosPrincipal InvestigatorM.D. Anderson Cancer Center
Sajad KhazalPrincipal InvestigatorM.D. Anderson Cancer Center