Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

NCT03258047 | Unknown Phase 2

• 1 other identifier: lymphoma center Q002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients. Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.

Conditions

B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• complete remission rate

  complete remission rate after treated by CAR-T therapy

  every 3 months until 20 months after the last patient's enrollment

Secondary Outcomes (4)

• progression free survival

  from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment

• overall survival

  20 months after the last patient's enrollment

• adverse events

  from the date of the start of treatment to 20 months after last patient's enrollment

• duration of the modified T cells by CAR-T in the patients

  from the date of re-transfusison to 20 months after last patient's enrollment

Study Arms (1)

CAR-T treatment

EXPERIMENTAL

In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated

Combination Product: CAR-T

Interventions

CAR-T COMBINATION_PRODUCT

CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.

CAR-T treatment

Eligibility Criteria

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

You may qualify if:

• Age≥18 years, male or female;
• Karnofsky≥60%；
• B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
• Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
• Patients have had more than 2 combined chemotherapy regimens;
• Creatinin \<2.5mg/dL；ALT/AST level \<3 times of the maximum of normal range; bilirubin\<3mg/dL；
• Proper venous condition for leukapheresis, no contraindication for leukapheresis;
• Patient that could understand and is willing to sign the written consent;
• Fertile female patient should be willing to take contraceptive measures.
• Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

You may not qualify if:

• Patients who need ≥15mg prednisone daily due to any cause;
• Patients with autoimmune disease and need immunosuppressor treatment;
• Serum creatinin\>2.5 mg/dL；serum AST \>5 times of normal maximum; bilirubin \>3 mg/Dl;
• FEV1\<2 L，diffusion capacity for carbon monoxide of lung (DLCO) \<40%；
• Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction\<35%；
• Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
• Patients that have previously received gene therapy of any kind;
• Obvious clinical encephalopathy or novel neuron function damage;
• Patients with active infection;
• Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
• Patients who had allergic history to agents of the similar structure as CAR-T;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 22, 2017
• Study Start: September 15, 2017
• Primary Completion: January 13, 2019
• Study Completion: July 30, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)