CAR-T CD19/CD20 for Patients With Advanced CD19/CD20+ B Cell Line Recurrent or Refractory Hematological Malignancies

NCT04700319 | Unknown Early Phase 1

• 1 other identifier: PA-CART-1920-I -001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study of CD19 / CD20 CAR-T cell infusion in the treatment of relapsed or refractory hematological malignancies in CD19 / CD20 positive B cell lines. The aim of this study was to evaluate the efficacy and safety of autologous chimeric antigen receptor T cell infusion targeting CD19/CD20 in the treatment of relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.

Conditions

CAR

Keywords

B cell line; hematological malignancies

Outcome Measures

Primary Outcomes (1)

• ORR 3

  3-month objective response rate

  three months after CAR-T cells infusion

Study Arms (1)

CD19/CD20 CAR-T cell infusion

EXPERIMENTAL

CD19/CD20 CAR-T cell infusion on relapsed or refractory hematological malignancies of CD19 / CD20+ B cell line

Drug: CD19/CD20 CAR-T cell infusion

Interventions

CD19/CD20 CAR-T cell infusion DRUG

CD19/CD20 CAR-T,Infusion,iv,0.2×10\^6-5×10\^6γδT /kg,once

Also known as: Targeting CD19、CD20 autologous chimeric antigen receptor T cells#

CD19/CD20 CAR-T cell infusion

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Only subjects meeting all of the following conditions were included in the study:
• The subjects who voluntarily participated in the study and signed the written informed consent;
• The age at the time of signing the informed consent is 3-70 years old, regardless of gender or race;
• The patients with CD19 / CD20 positive hematological malignancies without other effective treatment options include those who are not suitable for allogeneic stem cell transplantation (SCT) due to the following reasons:Age; Concurrent diseases; Other contraindications, such as total body irradiation (TBI) contraindications (TBI is one of the important treatment measures before allogeneic stem cell transplantation in all patients); Lack of suitable donors;
• Expected survival \> 12 weeks;
• Relapse after any stem cell transplantation (no matter what previous treatment plan); and;
• There was no active GVHD and no immunosuppression was required;
• Transplantation lasted more than 4 months;
• Serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl;
• Serum AST and alt ≤ 5 x upper limit of normal value (ULN);
• It is necessary to have indicators for disease detection or evaluation, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR;
• Cardiac function: left ventricular ejection fraction greater than or equal to 40%;
• ECoG physical condition (PS) ≤ 2;
• The pregnant test results of fertile female subjects within 48 hours before the infusion were negative and they were not in lactation period; all fertile female subjects took adequate contraceptive measures before entering the study and within 3 months after stopping the last infusion during the whole study period.

You may not qualify if:

• Pregnant or lactating female patients;
• Participate in another clinical trial within 4 weeks before the study, or intend to participate in another clinical trial during the whole study period;
• Uncontrolled active infection;
• The history of human immunodeficiency virus is known;
• Active hepatitis B or hepatitis C infection;
• The systemic steroid treatment is needed during cell infusion or cell collection, or there are some diseases that researchers think may need steroid treatment during blood collection or infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone for physiological replacement therapy in patients with adrenocortical insufficiency are also allowed;
• There are grade 2-4 acute or systemic chronic GVHD;
• There is GVHD under treatment;
• Patients with cns3 disease progression or central nervous system parenchymal lesions that may increase central nervous system toxicity; patients with active central nervous system leukemia or lymphoma infiltration;
• Absolute neutrophil count \< 750 / μ L or platelet count \< 50000 / μ l caused by non primary diseases;
• When collecting cells, they received systemic chemotherapy 2 weeks ago or radiotherapy 3 weeks ago;
• Researchers believe that it is not suitable to participate in this clinical trial due to various reasons.

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead
• Anhui Provincial Hospital: collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xingbing Wang

  No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingbing Wang

CONTACT

13856007984; wangxingbing@ustc.edu.cn

Huimin Meng

CONTACT

0551-65728070; huimin.meng@persongen.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: April 19, 2019
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

CN (1)