Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

NCT03226704 | Enrolling By Invitation

• 2 other identifiers: 17013717-C-0137
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Leukapheresis is a procedure to separate and collect white blood cells. It is the first step in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be offered to people when their cancer comes back. The collected T-cells are used to make a special version of T-cells called CARs. Researchers want to collect these cells from people who may become eligible for a CAR T-cell study in the future. Objective: To identify people who have a high likelihood to benefit from CAR T-cell therapy early in their disease course and collect and store a T-cell product. Eligibility: People ages 3-65 with a form of leukemia or lymphoma that has not been cured by standard therapy Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Review of existing MRI, x-ray, pathology specimens/reports or CT images may be done. On this study, participants will have leukapheresis. A needle will be placed into the arm. Blood will be collected and go through a machine. White blood cells will be taken out by the machine. The plasma and red cells will be returned to the participant through a second needle in the other arm. The procedure will take 4-6 hours. Some participants may have a central line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the needles in the arms-especially if they are smaller. For a central line placement, a long thin tube is inserted through a small incision into the main blood vessel leading into the heart that would allow access to the blood to do the leukapheresis procedure. Participants cells will be processed and frozen for future use in a CAR T-cell therapy study. ...

Conditions

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

Keywords

CD19; CD22; CD19/22; Immunotherapy; Apheresis; Natural History

Outcome Measures

Primary Outcomes (1)

• fraction of subjects who can enroll on a CAR-T study within approximately 12 months of undergoing apheresis

  number of subjects who enroll on a CAR-T study within approximately 12 months of undergoing apheresis

  12 months after collection of apheresis product

Secondary Outcomes (2)

• fraction of patients who experience a grade 4 toxicity associated with apheresis

  completion of apheresis procedure

• fraction of patients who can enroll on a CAR/adoptive cell therapy study within 12 months of undergoing apheresis by disease and type of CAR to be received.

  12 months after collection of apheresis product

Study Arms (1)

1

Patients \>/=3 - \</=65 years of age, at least 15 kg, with relapsed/refractory cancer that has recurred after or not responded to at least one standard regimen

Procedure: Leukapheresis

Interventions

Leukapheresis PROCEDURE

Leukapheresis

1

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 3-65 years of age, at least 15 kg, with relapsed/refractory cancer that has recurred after or not responded to one or more standard regimens and/or deemed incurable by standard therapy and who meet all eligibility criteria are eligible to participate.

You may qualify if:

• 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)
• AST(SGOT)/ALT(SGPT)\<=20 X institutional upper limit of normal for age and laboratory normal ranges
• creatinine within age adjusted normal institutional limits (see below) OR
• creatinine clearance \>= 60 mL/min/1.73 m\^2 for creatinine levels above institutional normal.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Srivandana Akshintala, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: August 14, 2017
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-05-18

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)