The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma

NCT03576807 | Unknown Phase 1

• 1 other identifier: SHLY1701
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.

Conditions

Relapsed or Refractory B-cell Lymphomas

Keywords

B-cell leukemia

Outcome Measures

Primary Outcomes (1)

• Study related adverse events [ Time Frame: 4 weeks ]

  Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible.

  4 weeks

Secondary Outcomes (1)

• Graft Activity Endpoint Detection

  24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart

Study Arms (1)

CD20 CAR-T cells

EXPERIMENTAL

Experimental: CD20 CAR-T cells

Drug: CD20 CAR-T cells

Interventions

CD20 CAR-T cells DRUG

A total of 1 - 20×10\^6 CD20 CAR-T cells/kg will be administered by IV infusions.

CD20 CAR-T cells

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ．Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation.
• The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%.
• \. Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications.
• ECOG评分≤2. 10. Patients need to sign informed consent.

You may not qualify if:

• The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
• Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.);
• The patient is an active hepatitis B or hepatitis C infection.
• The patient received genetic product treatment within six months.
• The patient participated in a clinical trial within six months.
• The patient has a severe autoimmune disease.
• The doctor thinks that there are other reasons that can't be accepted.

Sponsors & Collaborators

• Xin Wang: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell; Leukemia, B-Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

JIANG CAO, DOCTOR

CONTACT

+86 1385243263; zimu05067@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: SPONSOR INVESTIGATOR
• PI Title: The clinical research of targeted CD20-CART cells treatment for refractory or recurrence B lymphocyte lymphoma

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 3, 2018
• Study Start: April 4, 2018
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2020
• Last Updated: July 3, 2018

Record last verified: 2018-04

Locations

CN (1)