MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma

NCT ID: NCT03932955

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-05-01

Brief Summary

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.

Detailed Description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MC-19PD1 CAR-T Cells

Group Type: EXPERIMENTAL

MC-19PD1 CAR-T cells

Intervention Type: BIOLOGICAL

T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration.

Interventions

MC-19PD1 CAR-T cells

T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

（1）CD19 positive B-cell lymphoma; （2）Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; （3）At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; （4）18 to 70 Years Old, Male and female; （5）Expected to survive for more than 3 months; （6）Clinical performance status of ECOG score 0-1; （7）Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L.

（9）INR≤ 1.5times normal range; APTT≤ 1.5times normal range; （10）Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; （11）Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria

1. Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis;

2. Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections;

3. Active infection with HBV, HCV or HIV;

4. Patients with symptoms and disease history of central nervous system;

5. Pregnant or lactating female；The patient did not agree to use effective contraception during the treatment period and for the following 1 year；

6. Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation

7. A history of other malignant tumors;

8. Primary immunodeficiency disease, or autoimmune disease;

9. Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment;

10. Patients who participated in other clinical trials within 4 weeks before blood collection;

11. Patients who had used CD19 targeted therapy before enrollment;

12. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chaoting Zhang, PhD

Role: CONTACT

zhangchaoting1@163.com

86-010-88196768

Facility Contacts

Yuqin Song, PhD

Role: primary

songyuqin622@163.com

0086 ‭13683398726‬

Other Identifiers

MC-19PD1 CART201902

Identifier Type: -

Identifier Source: org_study_id