CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies

Recurrent or Refractory B Cell Malignancy Clinical Trial

Official title:

Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02794961
• Other study ID #: AF-08/04.2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 6, 2016
• Last updated: June 6, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2016
• Source: Xuzhou Medical College
• Contact: Jiang Cao, M.D., Ph.D.
• Phone: 8651685802291
• Email: zimu05067[@]163.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.

Description:

CD19 is an ideal target with great potential for treating B-cell-derived hematological malignancies. Although the complete remission rate is as high as 93% by using CD19-targeting CAR-T technology, approximately 60% patients will have recurrent disease. Among all the recurrent patients, two thirds is revealed to loss their CD19 expression on B cell surface. For overcoming this issue, we establish a new chimeric antigen receptor containing humanized single chain antibody sequence to target CD22 molecule on B cells.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 60 Years

Eligibility

Inclusion Criteria:

• Greater than four years of age

• Survival time>12 weeks

• B cell hematological malignancies by pathological examination

• Chemotherapy failure or recurrent B cell malignancy

• Creatinine< 2.5mg/dl

• Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level

• Bilirubin<2.0mg/dl

• Karnofsky Performance Status>50% at the time of screening

• Adequate pulmonary, renal, hepatic, and cardiac function

• Fail in autologous or allogenic haemopoietic stem cell transplantation

• Free of leukocytes removal contraindications

• Voluntarily join CAR-T clinical trial

• Understand and sign written informed consent

Exclusion Criteria:

• Pregnant or nursing women

• Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening

• Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated.

• Abnormal vital signs

• Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2

• General infection or local severe infection, or other infection that is not controlled

• Dysfunction in lung, heart, kidney and brain

• Severe autoimmune diseases

• Other symptoms that are not applicable for CAR-T

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Recurrent or Refractory B Cell Malignancy

Intervention

Biological:
• CD22 CAR-T
Autologous CAR-T cells with average 1*10^6 cells/kg body weight

Locations

Country	Name	City	State
China	Affiliated hospital of Xuzhou medical college	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Kai Lin Xu; Jun Nian Zheng	iCarTAB BioMed Inc.

Country where clinical trial is conducted

China, 

References & Publications (1)

Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ. Anti-CD22-chimeric antigen receptors targeting B-cell precursor acute lymphoblastic leukemia. Blood. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate	The B cells in peripheral blood of all enrolled patients will be monitored every week	12 months	No