CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Humanized CAR-T Therapy for Treatment of B Cell Malignancy

NCT02782351

Leukemia, Lymphocytic, Chronic, B-Cell

UNKNOWN PHASE1/PHASE2

Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies

NCT03262298

Leukemia Lymphoma

UNKNOWN PHASE1/PHASE2

A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies

NCT02935153

Leukemia Lymphoma

UNKNOWN PHASE1/PHASE2

A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies

NCT03999697

Diffuse Large B Cell Lymphoma Follicular Lymphoma Primary Cutaneous Follicle Centre Lymphoma +4 more

UNKNOWN PHASE1

The Clinical Application of Chimeric Antigen Receptor T Cells in the Treatment of CD19 Positive Recurrent Refractory B Cell-derived Hematological Malignancies

NCT04184414

B Acute Lymphoblastic Leukemia Mantle Cell Lymphoma Follicular Lymphoma

UNKNOWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent or Refractory B Cell Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CD22 CAR-T

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

Group Type EXPERIMENTAL

CD22 CAR-T

Intervention Type BIOLOGICAL

Autologous CAR-T cells with average 1\*10\^6 cells/kg body weight

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CD22 CAR-T

Autologous CAR-T cells with average 1\*10\^6 cells/kg body weight

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No