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Leukapheresis for CAR T-cell Therapy Manufacturing

This study is looking at leukapheresis, a procedure to collect your white blood cells. These cells are the first step in making CAR T-cell therapy, a special treatment for certain cancers like leukemia and lymphoma that have come back or haven't responded to other treatments. Researchers want to collect and store these cells from people who might need CAR T-cell therapy in the future. The main goal is to see how many people who undergo leukapheresis can then enroll in a CAR T-cell study within about a year. You may be able to join if you are between 3 and 65 years old, weigh at least 15 kg, and have a confirmed cancer diagnosis that is relapsed or refractory (meaning it has come back or not responded to at least one standard treatment).

Study design
This is an observational study aiming to enroll 120 participants. It is not a randomized trial and does not specify a phase.
What's involved
The main procedure for participants is leukapheresis, which is the collection of white blood cells. The record does not specify additional visits, tests, or the duration of participation beyond this collection.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to see if they can enroll in a CAR-T study within approximately 12 months after their cells are collected.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03226704

Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

Enrolling by Invitation
Not specifiedAges 3–65Observational
National Cancer Institute (NCI)
~120 participants
Updated 2026-09-16 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

Leukemia
Lymphoma
Acute Lymphoblastic Leukemia
Diffuse Large B Cell Lymphoma
Non-Hodgkin's Lymphoma

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NCT03226704

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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

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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