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

NCT03932955 | Unknown Phase 1

• 1 other identifier: MC-19PD1 CART201902
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percentage of adverse events

  Percentage of participants with adverse events

  2 years

Secondary Outcomes (1)

• objective remission rate

  3 months

Study Arms (1)

MC-19PD1 CAR-T Cells

EXPERIMENTAL

Biological: MC-19PD1 CAR-T cells

Interventions

MC-19PD1 CAR-T cells 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.

MC-19PD1 CAR-T Cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （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.

You may not qualify if:

• Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis;
• Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections;
• Active infection with HBV, HCV or HIV;
• Patients with symptoms and disease history of central nervous system;
• Pregnant or lactating female；The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
• Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation
• A history of other malignant tumors;
• Primary immunodeficiency disease, or autoimmune disease;
• Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment;
• Patients who participated in other clinical trials within 4 weeks before blood collection;
• Patients who had used CD19 targeted therapy before enrollment;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chaoting Zhang, PhD

CONTACT

86-010-88196768; zhangchaoting1@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 1, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

CN (1)