NCT03226704
Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing
Enrolling by Invitation
Not specifiedAges 3–65ObservationalNational Cancer Institute (NCI)Government-funded
~120 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Leukapheresis
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
fraction of subjects who can enroll on a CAR-T study within approximately 12 months of undergoing apheresis
Measured over 12 months after collection of apheresis product
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Srivandana Akshintala, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age: \>= 3 and \<= 65 years
Weight \>= 15 kg
Confirmation of cancer diagnosis provided by disease-specific assessment (e.g., flow cytometry, PCR) or H\&E verification.
Disease Status:
Relapsed/refractory cancer that has failed at least one standard regimen and are not in remission at the time of leukapheresis, OR
Previously treated patients without detectable disease at the time of leukapheresis but at high-relapse risk.
Potentially eligible for future NIH-CAR or other adoptive cell therapy based on the following:
Adequate performance status: Patients \> 10 years of age: Karnofsky \>= 50%; Patients \<= 10 years of age: Lansky scale \>= 50%
Adequate organ function:
absolute neutrophil count \>750/mcL\*
platelets \>=30,000/mcL\*
total bilirubin \<=2 X ULN (except in the case of subjects with documented Gilbert s disease \> 3x ULN)
Age (Years): \<=5; Maximum Serum Creatine (mg/dL): 0.8
Age (Years): 5 \< age \<= 10; Maximum Serum Creatine (mg/dL): 1.0
Age (Years): \>10; Maximum Serum Creatine (mg/dL): 1.2
Cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion.
Patients, parents/guardians, legally authorized representative (LAR), or durable power of attorney must be able to give consent and sign the Informed Consent Document.
Exclusion
Transfusion refractory thrombocytopenia such that platelet count cannot be adequately supported with transfusions to be at \>=30,000/mcL
Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
Rapidly progressive disease or hyperleukocytosis \>= 50,000 blasts/mcL
Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate CAR or adoptive cell therapy-based toxicity
Pregnant or nursing (lactating) individuals, where pregnancy is defined as the state of after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening
Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at screening
Human Immunodeficiency Virus (HIV) infection at screening (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities)
Any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures
What this trial measures
- fraction of subjects who can enroll on a CAR-T study within approximately 12 months of undergoing apheresis12 months after collection of apheresis product
number of subjects who enroll on a CAR-T study within approximately 12 months of undergoing apheresis