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Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies

NCT04767308 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-02-23

No results posted yet for this study

Summary

Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.

Conditions

  • CD5+ Relapsed/Refractory Hematopoietic Malignancies
  • Chronic Lymphocytic Leukemia (CLL)
  • Mantle Cell Lymphoma (MCL)
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Follicular Lymphoma (FL)
  • Peripheral T-cell Lymphomas (PTCL)

Interventions

BIOLOGICAL

CT125A cells

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT125A cells, during which cyclophosphamide and fludarabine will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT125A cells by intravenous (IV) infusion. The initial dose of 1×10\^6 CAR+ T cells/kg will be infused on day 0.

DRUG

Cyclophosphamide, fludarabine

Subjects will be given IV infusion of cyclophosphamide 500 mg/m2/day and fludarabine 30 mg/m2/day on days -4, -3 and -2

Sponsors & Collaborators

  • Shanghai IASO Biotechnology Co., Ltd

    collaborator INDUSTRY

  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Jianfeng Zhou, PhD, MD · Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2023-09-30
Completion
2023-12-31

More Related Trials

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 NCT04767308 on ClinicalTrials.gov