Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Study of CD22 CAR T Cells in the Treatment of Patients With Relapsed or Refractory CD22 Positive B Cells With Acute Lymphoblastic Leukemia |
Actual Study Start Date : | December 1, 2018 |
Estimated Primary Completion Date : | December 1, 2020 |
Estimated Study Completion Date : | December 1, 2020 |
Arm | Intervention/treatment |
---|---|
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.
|
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
|
Ages Eligible for Study: | 3 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
Contact: Lin Yang, Ph.D | 86-0551-65728070 | lin.yang@persongen.com.cn |
China, Anhui | |
PersonGen·Anke cellular therapeutics Co., Ltd | Recruiting |
Hefei, Anhui, China, 230088 | |
Contact: Lin Yang, Ph.D | |
Principal Investigator: Lin Yang, Ph.D |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 25, 2019 | ||||
First Posted Date ICMJE | June 27, 2019 | ||||
Last Update Posted Date | June 27, 2019 | ||||
Actual Study Start Date ICMJE | December 1, 2018 | ||||
Estimated Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
In vivo existence of Anti-CD22 CAR-T cells [ Time Frame: 2 years ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies | ||||
Official Title ICMJE | Clinical Study of CD22 CAR T Cells in the Treatment of Patients With Relapsed or Refractory CD22 Positive B Cells With Acute Lymphoblastic Leukemia | ||||
Brief Summary | 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) | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | 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
|
||||
Study Arms ICMJE | 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.
Intervention: Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
10 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 1, 2020 | ||||
Estimated Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
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:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 3 Years to 70 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03999697 | ||||
Other Study ID Numbers ICMJE | PG-CART-22-I-001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | ||||
Study Sponsor ICMJE | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | ||||
Collaborators ICMJE | Anhui Provincial Hospital | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |