CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma

NCT03118180 | Unknown Phase 1 DMC

• 1 other identifier: CART19-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• overall response rate

  the number of response patients/the number of total patients

  Up to 30 months

Study Arms (1)

CART19 group

EXPERIMENTAL

All patients were included for CART19 therapy

Biological: CD19 targeted chimeric antigen receptor T cells

Interventions

CD19 targeted chimeric antigen receptor T cells BIOLOGICAL

CD19 targeted chimeric antigen receptor T cells for refractory and relapsed B cell lymphoma

CART19 group

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed aggressive B cell lymphoma
• Chemotherapy-refractory disease, defined as one or more of the following:
• No response to first-line therapy (primary refractory disease); PD as best response to first-line therapy SD as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R- CHOP) with SD duration no longer than 6 months from last dose of therapy OR No response to second or greater lines of therapy PD as best response to most recent therapy regimen SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy OR Refractory post-ASCT Disease progression or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
• Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)
• Age 18 or older
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1
• ANC ≥1000/uL
• Platelet count ≥75,000/uL
• Absolute lymphocyte count ≥100/uL
• Adequate renal, hepatic, pulmonary and cardiac function defined as:
• Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min Serum ALT/AST ≤2.5 ULN Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome. Cardiac ejection fraction ≥ 50% ,no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings No clinically significant pleural effusion Baseline oxygen saturation \>92% on room air
• Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

You may not qualify if:

• History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
• History of Richter's transformation of CLL
• Autologous stem cell transplant within 6 weeks of planned CAR-C19 infusion
• History of allogeneic stem cell transplantation
• Prior CD19 targeted therapy with the exception of subjects who received CAR-C19 in this study and are eligible for re-treatment
• Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
• History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the K Medical Monitor.
• Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti- HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
• Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
• Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
• History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
• Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
• Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression

Sponsors & Collaborators

• Zhejiang University: lead
• Innovative Cellular Therapeutics Co., Ltd.: collaborator

Study Sites (1)

the First Affiliated Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• He Huang, Dr

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongxian Hu, Dr

CONTACT

15957162012; huyongxian2000@aliyun.com

He Huang, Dr

CONTACT

13605714822; huanghe@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 18, 2017
• Study Start: April 5, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

CN (1)