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

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.

Study Overview

• Status: Unknown
• Conditions: B Cell Lymphoma
• Intervention / Treatment: Combination product: CAR-T

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age≥18 years, male or female;
2. Karnofsky≥60%；
3. 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).
4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
5. Patients have had more than 2 combined chemotherapy regimens;
6. Creatinin <2.5mg/dL；ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL；
7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;
8. Patient that could understand and is willing to sign the written consent;
9. Fertile female patient should be willing to take contraceptive measures.
10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion Criteria:

1. Patients who need ≥15mg prednisone daily due to any cause;
2. Patients with autoimmune disease and need immunosuppressor treatment;
3. Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
4. FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%；
5. 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%；
6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
7. Patients that have previously received gene therapy of any kind;
8. Obvious clinical encephalopathy or novel neuron function damage;
9. Patients with active infection;
10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
11. Patients who had allergic history to agents of the similar structure as CAR-T;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAR-T treatment; In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated	Combination product: CAR-T; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	from date of inclusion to date of progression, relapse, or death from any cause	from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment
overall survival	from the date of inclusion to date of death, irrespective of cause	20 months after the last patient's enrollment
adverse events	any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure	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	time from re-transfusion to date when the modified T cells become non-detectable.	from the date of re-transfusison to 20 months after last patient's enrollment

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): January 13, 2019
• Study Completion (Anticipated): July 30, 2019

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: lymphoma center Q002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the data would be available on the corresponding website of the leading research center.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No