Clinical trial NCT03932955: MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
Official title: Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lymphoma
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Percentage of adverse events
timeFrame: 2 years
Secondary outcomes:
measure: objective remission rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References: