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Cell Therapy

NK Cells + SCT for Leukemia

Phase 1 & 2
Recruiting
Led By Jeremy Ramdial, MD
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 Myelodysplastic Syndromes (MDS) with intermediate or high-risk IPSS scores
Patients with Acute Myeloid Leukemia (AML) meeting high-risk features or specific mutations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days post-transplant
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of adding a natural killer cell treatment to the standard stem cell transplant for leukemia patients.

Who is the study for?
Adults aged 18-70 with certain myeloid malignancies (AML, MDS, CML) who have a compatible stem cell donor. They must weigh at least 42 kg and have good heart and lung function, as well as adequate liver and kidney function. Excluded are those with CNS involvement of cancer within the last 3 months, other active cancers (except nonmelanoma skin cancer), uncontrolled infections, or severe allergies to trial substances.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of KDS-1001 natural killer cells combined with standard stem cell transplant in treating acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML). The NK cells are from a third-party donor.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as inflammation in various organs, infusion-related reactions due to NK cells or chemotherapy agents used during transplantation like fatigue, nausea, risk of infection and possible organ toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My MDS is classified as intermediate or high-risk.
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My AML is considered high-risk or has specific mutations.
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I have a blood cancer and meet the specific donor requirements.
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My vital organs are functioning well.
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I am between 18 and 70 years old.
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I am mostly active and can care for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Adverse Event Failure

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Trial Design

8Treatment groups
Experimental Treatment
Group I: Total Body Irradiation One DoseExperimental Treatment1 Intervention
on Day -2, you may receive 1 dose of total body irradiation (TBI).
Group II: TacrolimusExperimental Treatment1 Intervention
Starting on Day 5, you will begin receiving tacrolimus to help lower the risk of GVHD. You will begin by receiving it nonstop by vein until you are able to take it by mouth. You will then take tacrolimus by mouth 2 times a day for about 3 months.
Group III: Mycophenolate mofetilExperimental Treatment1 Intervention
by mouth 3 times a day for 90 days or longer.
Group IV: MesnaExperimental Treatment1 Intervention
On Days 3 and 4, You will also receive mesna by vein over 30 minutes every 4 hours for a total of 10 mesna doses.
Group V: MelphalanExperimental Treatment1 Intervention
On Day -7, you will receive melphalan by vein over about 30 minutes.
Group VI: Fludarabine phosphateExperimental Treatment1 Intervention
On Days -7, -6, -5, and -4, you will receive fludarabine by vein about 1 hour.
Group VII: FilgrastimExperimental Treatment1 Intervention
Starting on Day 7, you will begin to receive filgrastim as an injection under the skin 1 time a day.
Group VIII: CyclophosphamideExperimental Treatment1 Intervention
On Days 3 and 4, you will receive cyclophosphamide by vein over about 3 hours to help lower the risk of graft-versus-host disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Tacrolimus
2011
Completed Phase 4
~4740
Mesna
2003
Completed Phase 2
~1380
Fludarabine phosphate
2007
Completed Phase 2
~360
Filgrastim
2000
Completed Phase 3
~3670
Melphalan
2008
Completed Phase 3
~1500
Mycophenolate mofetil
2014
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,341 Total Patients Enrolled
Jeremy Ramdial, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

KDS-1001 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05115630 — Phase 1 & 2
Myeloid Leukemia Research Study Groups: Mycophenolate mofetil, Tacrolimus, Total Body Irradiation One Dose, Cyclophosphamide, Mesna, Filgrastim, Melphalan, Fludarabine phosphate
Myeloid Leukemia Clinical Trial 2023: KDS-1001 Highlights & Side Effects. Trial Name: NCT05115630 — Phase 1 & 2
KDS-1001 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05115630 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you speak to any other research that has been conducted involving Melphalan?

"Currently, 1120 clinical trials investigating the use of Melphalan are underway with 208 in Phase 3. While some studies take place in Hamburg and Hessen, a total of 32017 sites across the globe offer this medication trial to patients."

Answered by AI

Does the research team accept participants below forty years old?

"This study requires participants that are between 18 and 70 years old. There are 1116 trials available for minors, while seniors have access to 4322 similar clinical studies."

Answered by AI

Are there any open slots for individuals to join this clinical experiment?

"Per the information on clinicaltrials.gov, this medical trial is still accepting participants. It was published to their website on April 8th 2022 and has been updated as recently as November 17th of the same year."

Answered by AI

Am I eligible to participate in this research program?

"This clinical trial seeks 24 individuals aged 18 to 70 with a diagnosis of leukemia, and meeting the following criteria: body weight greater than 42 kgs; an HLA-matched related or unrelated donor (A, B, C antigens and DRB1); presence of one or more high risk features such as a preceding MDS diagnosis or complex/monosomal karyotype."

Answered by AI

What is the scope of participant involvement in this research endeavor?

"Correct. According to the details present on clinicaltrials.gov, this research is currently recruiting participants; since it was initially posted on April 8th 2022 and updated most recently November 17th 2022. A total of 24 patients need to be enrolled from a single location."

Answered by AI

What ailment is Melphalan usually prescribed for?

"Melphalan is a commonly-prescribed treatment for atopic dermatitis. It can also be employed to address acute myelocytic leukemia, multiple sclerosis, and psoriasis."

Answered by AI
~2 spots leftby Jun 2024