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UnknownNCT01735604

Genetically Engineered Lymphocyte Therapy in Treating Patients With Lymphoma That is Resistant or Refractory to Chemotherapy

Pilot Study of Redirected Autologous T Cells Transduced to Express A CD20-Specific Chimeric Immunoreceptor in Patient With Chemotherapy Resistant or Refractory CD20+ Leukemia and Lymphoma

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Chinese PLA General Hospital · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may make the body build an 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 resistant or refractory to chemotherapy.

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD20 vector (referred to as CART-20 cells). II. Determine duration of in vivo survival of CART-20 cells. RT-PCR analysis of whole blood will be used to detect and quantify survival of CART-20 TCR zeta:4-1BB over time. SECONDARY OBJECTIVES: I. For patients with detectable disease, measure anti-tumor response due to CART-20 cell infusions. II. Estimate relative trafficking of CART-20 cells to tumor in bone marrow and lymph nodes. III. For patients with stored or accessible tumor cells (such as patients with active CLL, ALL, etc) determine tumor cell killing by CART-20 cells in vitro. IV. Determine if cellular or humoral host immunity develops against the murine anti-CD20, and assess correlation with loss of detectable CART-20 (loss of engraftment). V. Determine the relative subsets of CART-20 T cells (Tcm, Tem, and Treg). OUTLINE: Patients are assigned groups according to order of enrollment. Patients receive anti-CD20-CAR lentivirus vector-transduced autologous T cells with 41BB-gamma vector for 3-5 days 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 13 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALanti-CD20-CAR vector-transduced autologous T cellsanti-CD20-CAR vector-transduced autologous T cells
OTHERgenetically engineered lymphocyte therapygenetically engineered lymphocyte therapy

Timeline

Start date
2013-01-01
Primary completion
2017-05-01
Completion
2018-10-01
First posted
2012-11-28
Last updated
2015-09-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01735604. Inclusion in this directory is not an endorsement.