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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03932955

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 1, 2019

Study Description

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.

  • Condition or Disease:Lymphoma
  • Intervention/Treatment: Biological: MC-19PD1 CAR-T cells
  • Phase: Phase 1
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

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 15 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
Experimental: MC-19PD1 CAR-T Cells
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.
Outcome Measures
  • Primary Outcome Measures: 1. Percentage of adverse events [ Time Frame: 2 years ]
    Percentage of participants with adverse events
  • Secondary Outcome Measures: 1. objective remission rate [ Time Frame: 3 months ]
    The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR)
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts

Contact: Chaoting Zhang, PhD 86-010-88196768 zhangchaoting1@163.com

Locations

China, Beijing
Peking University Cancer Hospital
Beijing

Sponsors and Collaborators

Peking University

More Information
  • Responsible Party: Peking University
  • ClinicalTrials.gov Identifier: NCT03932955 History of Changes
  • Other Study ID Numbers: MC-19PD1 CART201902
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lymphoma Lymphoma, B-Cell