Your session is about to expire
← 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
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
2,992 Previous Clinical Trials
1,792,561 Total Patients Enrolled
David Marin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on high-dose steroids or certain immune treatments right before joining.I have not had an active autoimmune disease in the last year.I am currently on immunosuppressive therapy.My blood cancer cells show a high level of CD70.I am not using other cancer treatments.I can care for myself but may not be able to do active work.It's been over 3 weeks since my last strong cancer drug treatment.My heart functions well, with no serious fluid around it or uncontrolled heart rhythm problems.I've had radiotherapy on some cancer sites, but others haven't been treated.I will use effective birth control during and up to 3 months after the study.I will use effective birth control during and up to 3 months after the study.I am HIV positive with a detectable viral load.I have not had a stem cell transplant or donor lymphocyte infusion in the last 12 weeks.I have severe side effects from past treatments, as confirmed by my doctor.My lung function is good, with no significant fluid in my lungs and I can breathe well on my own.I weigh at least 40 kg.I am between 18 and 75 years old.I have an infection that isn't getting better with treatment.My cancer cells show high levels of CD70.My kidney function is within the required range.My liver function tests are within the required range and I don't have liver cirrhosis or ascites.I am between 18 and 75 years old.I have an active neurological disorder.I have been diagnosed with amyloidosis or POEMS syndrome.My cancer has spread to my brain or its coverings.I am currently receiving treatment for active graft-versus-host disease.I have no active cancer except for treated cervical pre-cancer or non-melanoma skin cancer.I have not had major surgery within the last 4 weeks.My organs are working well.I am able to live my life with some help.It's been over 3 weeks since my last strong cancer drug treatment.I am a woman capable of becoming pregnant and have not been menopausal for 24 months, nor have I been surgically sterilized.I meet the specific criteria for my disease.
Research Study Groups:
This trial has the following groups:- Group 1: Cyclophosphamide
- Group 2: CAR.70/IL15-transduced CB-NK cells
- Group 3: Fludarabine phosphate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger