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Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies

NCT04088890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-03-30

Study results available
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Summary

The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from adults with relapsed/refractory B-cell malignancies (leukemia and lymphoma).

Conditions

  • B-ALL
  • B-cell Non Hodgkin Lymphoma
  • DLBCL
  • Follicular Lymphoma Grade 3B

Interventions

DRUG

Fludarabine

Fludarabine 30 mg/m2

DRUG

Cyclophosphamide

Cyclophosphamide 500 mg/m2

DRUG

CD22 CAR

Autologous T cells transduced with lentiviral vector (CD22.BB.Z) Chimeric Antigen Receptor (CD22 CAR). Autologous CD22 CAR T cells will be administered intravenously at Dose Level 1 in subjects with ALL. Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) in subjects with aggressive B-cell NHL to determine MTD/RP2D

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • American Society of Hematology

    collaborator OTHER

  • Matthew Frank

    lead OTHER

Principal Investigators

  • Matthew Frank, MD, PhD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2024-11-07
Completion
2025-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT04088890 on ClinicalTrials.gov