CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies

Kai Lin Xu; Jun Nian Zheng

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Recurrent or Refractory B Cell Malignancy

Treatments: Biological: CD22 CAR-T

Study type: Interventional

Funder types: Other

Identifiers

NCT02794961

AF-08/04.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 4 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CD22 CAR-T

Experimental group

Description:

Enrolled patients will receive three escalating doses of autologous CAR-T.

Treatment:

Biological: CD22 CAR-T