← Back to Search

CAR T-cell Therapy

NK Cells + Chemotherapy for Blood Cancers

Phase 1 & 2
Recruiting
Led By David Marin, 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
Adequate organ function: Renal: Serum creatinine </= 1.5 mg/dL and estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) >/= 30 ml/min/1.73 m2. Hepatic: ALT/AST </= 2.5 x ULN or </= 5 x ULN if documented liver metastases, Total bilirubin </= 1.5 mg/dL, except in subjects with Gilbert's Syndrome in whom total bilirubin must be </= 3.0 mg/dL. No history of liver cirrhosis. No ascites. Cardiac: Cardiac ejection fraction >/= 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease. Pulmonary: No clinically significant, , pleural effusion (per PI discretion), baseline oxygen saturation > 92% on room air and adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) >50%.
Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test if it is safe to give NK cells along with standard chemotherapy to patients with leukemia, lymphoma, or multiple myeloma.

Who is the study for?
Adults aged 18-75 with certain blood cancers (like leukemia, lymphoma) that have a specific marker called CD70. They must be at least 3 weeks out from their last chemotherapy, have good organ function, and not be pregnant or fathering a child. Participants need to use effective birth control during the study and for three months after.Check my eligibility
What is being tested?
The trial is testing whether donor-derived natural killer (NK) cells engineered with CAR.70/IL15 can fight cancer when given alongside chemo drugs Cyclophosphamide and Fludarabine phosphate. It's in early stages to check safety and how well it works.See study design
What are the potential side effects?
Possible side effects include reactions related to immune cell infusion, effects of chemotherapy like nausea, fatigue, hair loss, increased risk of infections due to low blood counts, liver or kidney issues from drug toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood cancer cells show a high level of CD70.
Select...
I can care for myself but may not be able to do active work.
Select...
My heart functions well, with no serious fluid around it or uncontrolled heart rhythm problems.
Select...
I will use effective birth control during and up to 3 months after the study.
Select...
I weigh at least 40 kg.
Select...
I am between 18 and 75 years old.
Select...
My cancer cells show high levels of CD70.
Select...
My kidney function is within the required range.
Select...
I am between 18 and 75 years old.
Select...
I am able to live my life with some help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year 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 Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0.
Number of Participants who are Alive and in Remission
Number of Participants with Complete or Partial Response

Trial Design

3Treatment groups
Experimental Treatment
Group I: Fludarabine phosphateExperimental Treatment2 Interventions
Fludarabine is dosed using actual body weight.
Group II: CyclophosphamideExperimental Treatment2 Interventions
Cyclophosphamide is dosed per adjusted body weight for patients weighing > 20% above their ideal body weight using the calculation.
Group III: CAR.70/IL15-transduced CB-NK cellsExperimental Treatment1 Intervention
Patients will receive a single flat dose of CAR-NK.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine phosphate
2007
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,227 Total Patients Enrolled
David Marin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

CAR.70/IL15-transduced CB-NK cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05092451 — Phase 1 & 2
B-Cell Lymphoma Research Study Groups: Cyclophosphamide, CAR.70/IL15-transduced CB-NK cells, Fludarabine phosphate
B-Cell Lymphoma Clinical Trial 2023: CAR.70/IL15-transduced CB-NK cells Highlights & Side Effects. Trial Name: NCT05092451 — Phase 1 & 2
CAR.70/IL15-transduced CB-NK cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05092451 — 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 provide details of any former experiments that have included CAR.70/IL15-transduced CB-NK cells?

"Currently, 908 clinical trials are investigating the efficacy of CAR.70/IL15-transduced CB-NK cells, with 161 in their third phase. Though Philadelphia is home to most of these studies, there exist 28475 sites running similar experiments across the globe."

Answered by AI

How many enrollees are currently contributing to this clinical research endeavor?

"Affirmative. According to clinicaltrials.gov, the research study is presently accepting participants. The trial was initially announced on November 1st 2022 and has been revised recently on that same date for 94 individuals from one location."

Answered by AI

Is recruitment currently being conducted for this trial?

"The clinical trial details hosted on clinicaltrials.gov show that this medical study is actively looking for patients, and the post was initially published on November 1st 2022 before being revised at a later date."

Answered by AI

What types of ailments are alleviated through the use of CAR.70/IL15-transduced CB-NK cells?

"CAR.70/IL15-transduced CB-NK cells can be deployed to treat multiple sclerosis, leukemia, myelocytic, acute and retinoblastoma patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
2022. "Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05092451.
~58 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top