A Study of CD19/22 CART Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Lymphoma

NCT ID: NCT04539444

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-02-01

Brief Summary

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.

Detailed Description

Though response rates have greatly improved with the development of Chimeric antigen receptor T cells (CART) therapy in refractory/relapsed B cell non-Hodgkin's lymphoma (R/R B-NHL), the response can't usually last long and relapse occurs in a large proportion of patients who receive CART cells infusion. The main reasons of relapse might be tumor antigen loss and a lack of CART cell persistence. Currently, preclinical studies have shown that there is a synergistic effect between CAR-T cell therapy and anti-PD1 pathway, and it did have efficacy in clinic. In parallel, the combined use of CART-19 and CART-22 cells has a better potential to reduce antigen escape and increase anti-tumor activity. Therefore, the combination of CD19/22 CART and PD-1 inhibitor is one of the ways to improve the therapeutic effect of CART cells. This study was conducted to explore the efficacy and safety of CD19/22 CART cells in R/R B-NHL.

Conditions

Relapsed Non Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Study Design

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

Study Groups

CD19/22 CART cells combined with PD-1 inhibitors

Patients will receive PD-1 inhibitor on the first day after CART cell infusion

Group Type: EXPERIMENTAL

CD19/22 CART

Intervention Type: BIOLOGICAL

CD19/22 CART cells are administrated in a 3-day split-dose regimen at dose of 0.5- 2×10\*107 CART cells per kilogram of body weight.

Tislelizumab

Intervention Type: DRUG

Patients will receive Tislelizumab 200mg/dose every 3 weeks.

Interventions

CD19/22 CART

CD19/22 CART cells are administrated in a 3-day split-dose regimen at dose of 0.5- 2×10\*107 CART cells per kilogram of body weight.

Intervention Type: BIOLOGICAL

Tislelizumab

Patients will receive Tislelizumab 200mg/dose every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

PD-1 inhibitor

Eligibility Criteria

Inclusion Criteria

1. R/R B-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry ( meeting any of the following conditions):

A.The lesion shrinkage <50% or disease progression after 4 courses of standard first-line treatment or 2 courses of two-line treatment (primary refractory disease) B. Progress disease as the best response after hematopoietic stem cell transplantation C.Progress disease or stable disease as the best response to most recent therapy regimen

2. Age ≥ 18 years

3. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points

4. The main organ functions need to meet the following conditions:

A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2 upper limitation of normal D.SpO2 > 90%

5. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion

6. Expected survival exceeds 3 months

7. Written informed consent could be acquired

Exclusion Criteria

1. Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years

2. Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection

3. Active hepatitis B or hepatitis C infection

4. HIV infection

5. Severe acute or chronic graft-versus-host disease (GVHD)

6. Participated in any other drug research clinical trials within 30 days before enrollment

7. Prior CART cells therapy within 3 months before enrollment

8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment

9. Have contraindications to the PD-1 inhibitors

10. Uncontrolled other tumor

11. Women in pregnancy,lactation or planning to become pregnant

12. The researcher considers inappropriate to participate in this research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Depei Wu, M.D.

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Caixia Li, M.D.

Role: CONTACT

licaixia@suda.edu.cn

+86 512 67781856

Jia Chen, M.D.

Role: CONTACT

chenjiasuzhou@gmail.com

+86 512 67781856

Facility Contacts

Caixia Li

Role: primary

Other Identifiers

CCPD-1 in lymphoma

Identifier Type: -

Identifier Source: org_study_id