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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after the nk cell infusion for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT03019640

100%

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%

Rash maculo-papular

55%

Edema limbs

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%

Bloating

14%

Hypermagnesemia

14%

Dyspepsia

14%

Paresthesia

14%

Rectal pain

14%

Infusion related reaction

14%

Immune system disorders

14%

INR increased

14%

Pleural effusion

Back pain

Renal and urinary disorders

Arthritis

Blood bilirubin increased

Upper respiratory infection

Sore throat

Bone pain

Creatinine increased

Skin ulceration

Cholesterol high

Dry skin

Dysgeusia

Hypernatremia

Flushing

Non-cardiac chest pain

General disorders and administration site conditions

Hyperuricemia

Nasal congestion

Papulopustular rash

Skin hyperpigmentation

Hypercalcemia

Bladder infection

Gastrointestinal pain

Ear pain

Eye disorders

Nervous system disorders

Tremor

Urinary frequency

Encephalopathy

Respiratory failure

Lung

Atrial fibrillation

Epistaxis

Urinary tract infection

Atelectasis

Rash acneiform

Flatulence

Acute kidney injury

Weight gain

Gastroesophageal reflux disease

Thromboembolic event

Edema face

Endocrine disorders

Metabolism and nutrition disorders

Mucosal infection

Neck pain

Prostatic obstruction

Pulmonary edema

Hematuria

Hemorrhoidal hemorrhage

Hypoglycemia

Musculoskeletal and connective tissue disorder

Myalgia

Hypothyroidism

Lung infection

Lymph node pain

Lymphocyte count increased

Pain in extremity

Peripheral motor neuropathy

Restlessness

Sinus bradycardia

Sinusitis

Skin and subcutaneous tissue disorder

Urinary tract pain

Vascular disorders

Ileus

100%

80%

60%

40%

20%

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

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