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

Lymphoma Clinical Trial

Official title:

Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932955
• Other study ID #: MC-19PD1 CART201902
• Status: Recruiting
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2019
• Source: Peking University
• Contact: Chaoting Zhang, PhD
• Phone: 86-010-88196768
• Email: zhangchaoting1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of adverse events	Percentage of participants with adverse events	2 years
Secondary	objective remission rate	The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR)	3 months