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T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma

NCT04160195 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-02-15

Study results available
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Summary

Background:

-Cluster of differentiation 19 (CD19) and cluster of differentiation 20 (CD20) are often found on certain cancer cells. Researchers think that a person's T cells can be modified in a lab to kill cells that have CD19 and CD20 on the surface.

Objective:

-To see if it is safe to give anti-CD19 and anti-CD20 CAR T cells to people with a B cell cancer or Hodgkin lymphoma.

Eligibility:

-People ages 18 and older with a B cell cancer or Hodgkin lymphoma that has not been controlled with standard therapies

Design:

* Participants will be screened under protocol 01C0129 with:
* Medical history
* Physical exam
* Blood and heart tests
* Bone marrow biopsy: A needle is inserted into the participant's hip bone to remove a small amount of marrow.

Scans

* Participants will have apheresis: Blood will be removed through a vein. The blood with circulate through a machine that removes the T cells. The rest of the blood will be returned to the participant.
* Once a day for 3 days before they get the T cells, participants will receive chemotherapy through a vein.
* Participants will receive the T cells through a vein. They will stay in the hospital for at least 9 days.
* Participants may have a lumbar puncture: A needle will remove fluid from the spinal cord.
* Participants may have a tumor biopsy.
* Participants will repeat the screening tests throughout the study.
* Participants will have follow-up visits 2 weeks after infusion; monthly for 4 months; at 6, 9, and 12 months; every 6 months for 3 years; and then annually for 5 years. Participants will then be contacted annually for 15 years.

Conditions

Interventions

BIOLOGICAL

Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells

Dose-escalation trial starting dose: 0.66 x10\^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10\^6 CAR+ T cells/kg based on cohort) infuse on day 0

DRUG

Cyclophosphamide

500 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3

DRUG

Fludarabine

30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • James N Kochenderfer, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2021-06-11
Completion
2021-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160195 on ClinicalTrials.gov