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

NCT04539444 | Unknown Phase 2

• 1 other identifier: CCPD-1 in lymphoma
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed Non Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Keywords

Chimeric antigen receptor T cells; Relapsed or refractory B cells non-Hodgkin's lymphoma; PD-1 inhibitor

Outcome Measures

Primary Outcomes (2)

• Overall response rate (ORR)

  Number of patients who achieved response (complete response and partial response ) after treatment of CD19/22 CART combined with PD-1 inhibitor. Response will be assessed using the Lugano criteria.

  1 year

• Progression-free survival(PFS)

  PFS will be assessed from the first CART cell infusion to progression,death or last follow-up.

  1 year

Secondary Outcomes (4)

• Complete relapse rate(CR)

  1 year

• Duration of overall response (DOR)

  1 year

• Overall survival(OS)

  1 year

• Incidence of treatment-related adverse events

  1 year

Study Arms (1)

CD19/22 CART cells combined with PD-1 inhibitors

EXPERIMENTAL

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

Biological: CD19/22 CART; Drug: Tislelizumab

Interventions

CD19/22 CART 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.

CD19/22 CART cells combined with PD-1 inhibitors

Tislelizumab DRUG

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

Also known as: PD-1 inhibitor

CD19/22 CART cells combined with PD-1 inhibitors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥ 18 years
• The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
• 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%
• Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
• Expected survival exceeds 3 months
• Written informed consent could be acquired

You may not qualify if:

• Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
• Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection
• Active hepatitis B or hepatitis C infection
• HIV infection
• Severe acute or chronic graft-versus-host disease (GVHD)
• Participated in any other drug research clinical trials within 30 days before enrollment
• Prior CART cells therapy within 3 months before enrollment
• Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
• Have contraindications to the PD-1 inhibitors
• Uncontrolled other tumor
• Women in pregnancy,lactation or planning to become pregnant
• The researcher considers inappropriate to participate in this research

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Interventions

tislelizumab; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Depei Wu, M.D.

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Caixia Li, M.D.

CONTACT

+86 512 67781856; licaixia@suda.edu.cn

Jia Chen, M.D.

CONTACT

+86 512 67781856; chenjiasuzhou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: August 2, 2021

Record last verified: 2020-08

Locations

CN (1)