Clinical Trials Directory

Trials / Completed

CompletedNCT03097770

Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD20

Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Chinese PLA General Hospital · Academic / Other
Sex
All
Age
16 Years – 70 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.

Detailed description

PRIMARY OBJECTIVES: To assess the efficacy of TanCAR19/20 T cells in relapsed or refractory NHL, defined as overall response rate (ORR). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of TanCAR19/20 T cells. II. To evaluate time to response (TTR), duration of overall response (DOR), progression free survival (PFS) and overall survival (OS). III. To determine in vivo expansion and persistence of TanCAR19/20 T cells. OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-CD19/20-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on day1 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 3 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALanti-CD19/20-CAR vector-transduced T cellsgenetically engineered lymphocyte therapy

Timeline

Start date
2017-04-01
Primary completion
2019-05-10
Completion
2020-01-31
First posted
2017-03-31
Last updated
2020-09-02

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03097770. Inclusion in this directory is not an endorsement.