CART-19 Immunotherapy in Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title:

Anti-CD19 Chimeric Antigen Receptor Modified T Cells Infusion in Mantle Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081937
• Other study ID #: CN301-XYK-CAR001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 6, 2014
• Last updated: March 10, 2014
• Start date: March 2014
• Est. completion date: December 2019

Study information

• Verified date: March 2014
• Source: Chinese PLA General Hospital
• Contact: Quanshun Wang, Dr.
• Phone: 8610-66939486
• Email: wqs63[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Chinese PLA General Hospital
• Study type: Interventional

Clinical Trial Summary

Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an escalating dose. After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.

Description:

PRIMARY OBJECTIVES:

I. Determine the safety and efficacy of the chimeric antigen receptor T cells transduced with the anti-CD19 (cluster of differentiation antigen 19 ) vector (referred to as CART-19 cells) in elderly patients with MCL.

II. Determine duration of in vivo survival of CART-19 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-19 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.

SECONDARY OBJECTIVES:

For patients with detectable disease, measure anti-tumor response due to CART-19 cell infusions.

Estimate relative trafficking of CART-19 cells to tumor in bone marrow and lymph nodes.

Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable CART-19 (loss of engraftment).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female with CD19+ relapsed or refractory MCL, and with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.

• Not eligible or appropriate for conventional allogeneic SCT

• Patients who achieve only a partial response to FCR(fludarabine, cyclophosphamide and Rituxan) as initial therapy will be eligible.

• Beyond 1st CR (complete remission) with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT

• Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc...)

• Relapsed after prior autologous SCT

• Residual disease after primary therapy and not eligible for autologous SCT

• Relapsed after prior autologous SCT

• Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate of conventional allogeneic or autologous SCT

• Expected survival > 12 weeks

• Creatinine < 2.5 mg/dl

• ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal

• Bilirubin < 2.0 mg/dl

• Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy

• Adequate venous access for apheresis, and no other contraindications for leukapheresis

• Voluntary informed consent is given

Exclusion Criteria:

• • Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.

• Uncontrolled active infection

• Active hepatitis B or hepatitis C infection

• Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary

• Previously treatment with any gene therapy products

• Feasibility assessment during screening demonstrates < 30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD137 costimulation

• Any uncontrolled active medical disorder that would preclude participation as outlined

• HIV infection

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Non-hodgkin Lymphoma,B Cell

Intervention

Biological:
• anti-CD19-CAR vector-transduced T cells

Locations

Country	Name	City	State
China	Department of Hematology of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of study related adverse events	defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to the study.	Until 2 years	Yes
Secondary	Clinical responses to CART-19 cell therapy		Until 24 weeks	No