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Personalized NK Cell Therapy for Blood Cancer

Phase 2

Recruiting

Led By Katy Rezvani

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

Patients with options for treatment that are known to be curative are not eligible

Chronic myeloid leukemia (CML) second chronic phase or accelerated phase

Must not have

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

Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new way of using cord blood to treat patients with leukemia, lymphoma, or multiple myeloma who have received chemotherapy and a cord blood transplant.

Who is the study for?

This trial is for patients aged 15-80 with various blood cancers or myelodysplastic syndromes who have not responded well to standard treatments. They must be physically able to tolerate the transplant, with specific heart, kidney, and liver function requirements. Women of childbearing age must test negative for pregnancy. Those with curative treatment options elsewhere or certain serious health conditions are excluded.

What is being tested?

The study tests personalized NK cell therapy following chemotherapy and umbilical cord blood transplantation in patients with leukemia, lymphoma, multiple myeloma, or myelodysplastic syndrome. It aims to see if NK cells can kill remaining tumor cells and reduce graft versus host disease after transplant.

What are the potential side effects?

Potential side effects include reactions from the body's immune response to new cells, complications from high-dose chemotherapy like nausea and hair loss, increased risk of infections due to weakened immunity post-transplantation, and possible organ damage related to the conditioning regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any curative treatment options available.

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My CML is in the second chronic or accelerated phase.

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I have a type of MDS that might need a transplant or falls into one of several high-risk categories.

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My non-Hodgkin's lymphoma is in remission or has relapsed, but I don't have curative treatment options.

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My multiple myeloma is advanced and needs treatment.

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I have a specific type of blood cancer, such as AML, that is at high risk or beyond first remission.

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My heart pumps at least 40% of its blood each time it beats.

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My lung function tests show at least half the normal capacity for oxygen exchange.

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I can care for myself but cannot carry on normal activity or do active work.

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My kidney function is normal or meets the minimum required level.

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I am not pregnant and have had a period in the last 12 months.

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My SLL or CLL has worsened despite two standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe health issues that my current treatments can't control.

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I have a matching stem cell donor available.

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I have an active brain or spinal cord tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS) time in C1 patients

Progression free survival (PFS) time in C2C2 patients

Secondary study objectives

Incidence of graft-versus host disease

Incidence of infection

Incidence of transplant related mortality

+1 more

Side effects data

From 2022 Phase 2 trial • 6 Patients • NCT03096782

100%

Rash

100%

Mucositis

100%

Nausea

67%

Diarrhea

67%

HHV6 infection

67%

Hypertension

50%

Dyspnea

50%

Headache

50%

Constipation

50%

Insomnia

50%

Neutropenic fever

50%

Urinary Tract Infection (BK virus)

50%

Vomiting

33%

Chills

33%

Hyperglycemia

33%

Congestion

33%

Platelet Infusion Reaction

33%

Neuropathy

33%

Tachycardia

17%

Norovirus

17%

Fatigue

17%

DVT (thrombosis)

17%

Arthralgia

17%

Deconditioning

17%

BK cystitis

17%

Blurry vision

17%

Folliculitis

17%

Crackles to right lung

17%

Hand-foot syndrome

17%

Joint swelling

17%

Febrile neutropenia

17%

Peripheral edema

17%

Hyperbilirubinemia

17%

Chest tightness

17%

BK virus

17%

Arm pain

17%

Bone pain

17%

Flu-like Symptoms

17%

Fever

17%

Dysuria

17%

Anxiety

17%

Epistaxis

17%

Indigestion (dyspepsia)

17%

Blurred Vision

17%

Generalized body aches

17%

Ingrown toenail

17%

Hypotension

17%

Parainfluenza URI

17%

E. Coli pneumonia

17%

Cough

17%

Dry Eyes

17%

Fluid Imbalance

17%

Fluid Overload

17%

Decreased Appetite

17%

Hematochezia

17%

Hemorrhoids

17%

CMV infection

17%

Int elevated ALT

17%

Lower back pain

17%

Malnutrition

17%

Migraine

17%

Myalgia

17%

Vaginal irritation

17%

Weakness

17%

Transaminitis

17%

Sore Throat

17%

Abdominal pain

17%

Abnormal coagulopathy

17%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy and Cord Blood Transfusion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Reduced intensity regimen 3Experimental Treatment6 Interventions

Patients receive anti-thymocyte globulin IV over 4 hours on days -7 and -6, fludarabine phosphate IV over 1 hour on days -5 to -2, and melphalan IV over 30 minutes on day -2. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.

Group II: Non-myeloablative regimen 2Experimental Treatment8 Interventions

Patients with CD20 positive malignancies receive rituximab IV over 6 hours on day -9. Patients receive anti-thymocyte globulin IV over 4 hours on days -8 and -7, fludarabine phosphate IV over 1 hour on days -6 to -3, and cyclophosphamide IV over 3 hours on day -6 and undergo TBI on day -1 at the discretion of the investigator(s). UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.

Group III: Myeloablative regimen 1Experimental Treatment8 Interventions

Patients receive anti-thymocyte globulin IV over 4 hours on days -9 and -8, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -7 to -4. Patients undergo TBI on day -3. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Umbilical Cord Blood Transplantation

2009

Completed Phase 2

~470

Anti-Thymocyte Globulin

2009

Completed Phase 4

~1040