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

Study Purpose

Evaluation of the efficacy and safety of CD22-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of recurrent or refractory CD22 positive B cell acute lymphoblastic leukemia (B-ALL)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 3 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Male and female subjects with CD22+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD22-CAR-T cell therapy trials may be eligible if their CD22-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD22-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria: 1. Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD22+. 2. Patients 3 years of age or older, and must have a life expectancy > 12 weeks. 3. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60. 4. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR CD22 cells. 5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration. 6. Ability to give informed consent.

Exclusion Criteria:

1. Patients with symptomatic central nervous system (CNS) involvement. 2. Pregnant or nursing women may not participate. 3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 4. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders. 5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 6. Previously treatment with any gene therapy products. 7. The existence of unstable or active ulcers or gastrointestinal bleeding. 8. Patients with a history of organ transplantation or are waiting for organ transplantation. 9. Patients need anticoagulant therapy (such as warfarin or heparin). 10. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03999697
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Primary Cutaneous Follicle Centre Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Mantle Cell Lymphoma, Plasma Cell Neoplasm, B Cell Lymphoma
Arms & Interventions

Arms

Experimental: CAR-CD22 Cell immunotherapy

Enrolled patients will receive CAR-CD22 cell immunotherapy with a novel specific chimeric antigen receptor targeting CD22 antigen by infusion.

Interventions

Drug: - Autologous chimeric antigen receptor T cell transfusing agent targeting CD22

The enrolled patients will receive autologous-derived CD22-targeted CAR-T cells in 1 day with 100% of the total expected dosage after receiving lymphodepleting chemotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hefei, Anhui, China

Status

Recruiting

Address

PersonGen·Anke cellular therapeutics Co., Ltd

Hefei, Anhui, 230088

Site Contact

Lin Yang, Ph.D

lin.yang@persongen.com.cn

86-0551-65728070