Clinical trial NCT03262298: Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
Official title: Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Leukemia
Lymphoma
Keywords: CD22
CAR-T
Leukemia
Lymphoma
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.

Detailed description: Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-65 years
2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry
3. Refractory or relapsed B cell-acute lymphoblastic leukemia
4. No available curative treatment options (such as hematopoietic stem cell transplantation)
5. Stage III-IV disease
6. Creatinine \< 2.5 mg/dl
7. Aspartate transaminase-alanine transaminase ratio \< 3x normal
8. Bilirubin \< 2.0 mg/dl
9. Karnofsky performance status \>= 60
10. Expected survival time \> 3 months
11. Adequate venous access for apheresis
12. Ability to understand and provide informed consent

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients requiring T cell immunosuppressive therapy
3. Active central nervous system leukemia
4. Any concurrent active malignancies
5. Patients with a history of a seizure disorder or cardiac disorder
6. Previous treatment with any immunotherapy products
7. Patients with human immunodeficiency virus, hepatitis B or C infection
8. Uncontrolled active infection

Primary outcomes:
measure: Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
timeFrame: 2 years
Secondary outcomes:
measure: Overall Complete Remission Rate (ORR)
timeFrame: 2 years
measure: Disease response(CR, CRi)
timeFrame: 2 years
measure: CART cells persistence in vivo
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fengtai District
state: Beijing
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Liangding Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: