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CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

H

Henan Cancer Hospital

Status and phase

Unknown
Phase 1

Conditions

B-Cell Lymphoma Stage I
Relapsed
Refractory

Treatments

Biological: CD19/CD20 bispecific CAR-T cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03881761
HenanCH CART 2-3

Details and patient eligibility

About

Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Full description

CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Enrollment

50 estimated patients

Sex

All

Ages

17 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • expected lifetime>3 months
  • CD19/CD20 positive relapsed/refractory B cell lymphoma
  • KPS>70
  • at least one measurable lesion according to RECIST 1.1
  • enough function of hear, liver, kidney and bone marrow
  • no history of severe allergies
  • no other history of malignancy
  • no other diseases that conflict with this regimen
  • no serious mental illness
  • patient or family member sign informed consent

Exclusion criteria

  • Pregnant or lactating women
  • Severe infectious or viral disease
  • Active B or C viral hepatitis
  • Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
  • participated in other clinical studies in the last 3 months, or have been treated with other gene products
  • Others not appropriate to participate in this study examined by the investigators

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

experimental arm
Experimental group
Description:
CAR-T cell group
Treatment:
Biological: CD19/CD20 bispecific CAR-T cells

Trial contacts and locations

2

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Central trial contact

Yongping Song, Dr.; Quanli Gao, Dr.

Data sourced from clinicaltrials.gov

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