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CD19 and CD22 Dual-targeted CAR-T Cells for Relapsed or Refractory B-NHL | Clinical Trials | Clareo Health

UNKNOWNEARLY_PHASE1

CD19 and CD22 Dual-targeted CAR-T Cells for Relapsed or Refractory B-NHL

CD19 and CD22 Dual-targeted CAR-T Cells for Relapsed or Refractory B-NHL: a Multi-center, Uncontrolled Trial.

NCT04303247•Xinqiao Hospital of Chongqing

Summary

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, combining CD19 and CD22 as dual-targets for CAR-T cells, which adapt the FasT CAR-T cells manufacture technology to shorten the manufacture time and maintain the stemness of CAR-T cells. We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B-cell NHL to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must meet the following criteria for inclusion in the study： 1) Male or female subjects between the ages of 18 and 75（including critical values）； 2) Subjects histologically confirmed as diffuse diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), primary mediastinal B cell lymphoma (PMBCL) and mantle cell lymphoma (MCL) ：
•a） Refractory B-NHL ：Subjects of which the best response to standard first-line treatment is PD,(those intolerant to first-line treatment will not be included in this study). Subjects of which the best response to at least four courses of first-line treatment is SD, with a duration of SD less than 6 months after the last treatment. Subjects of which the best response to the last course of second-line treatment or above treatments is PD or the best response to at least two courses of second-line treatment or above treatments is SD, with a duration of SD less than 6 months.
•1. Male or female subjects between the ages of 18 and 75（including critical values）；
•2. Subjects histologically confirmed as diffuse diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), primary mediastinal B cell lymphoma (PMBCL) and mantle cell lymphoma (MCL) ：
•1. Refractory B-NHL ：Subjects of which the best response to standard first-line treatment is PD,(those intolerant to first-line treatment will not be included in this study). Subjects of which the best response to at least four courses of first-line treatment is SD, with a duration of SD less than 6 months after the last treatment. Subjects of which the best response to the last course of second-line treatment or above treatments is PD or the best response to at least two courses of second-line treatment or above treatments is SD, with a duration of SD less than 6 months.
•2. Relapsed B-NHL：The disease relapses confirmed by histopathology in subjects who achieved complete remission after standard systematic treatment and second-line treatment. Or the disease relapses confirmed by histopathology within 1 year after hematopoietic stem cell transplantation (not limited to the previous therapeutic regimen) ；
•3. Previous treatment must include CD20 monoclonal antibody (except patients with CD20 negative B cell NHL) and anthracycline；
•4. Subjects with TFL must receive chemotherapy before transformation and meet the above definition of relapse or refractory after transformation.
•3. According to Lugano response criteria 2014, there should be at least one evaluable tumor focus: the longest diameter of intranodal focus \> 1.5cm, the longest diameter of extranodal focus \> 1.0cm；
•4. Positive expression of CD19 or CD22 in tumor tissue；
+16 more criteria

Exclusion Criteria

•Any of the following points shall be deemed as no entry into this study：
•1. Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years)；
•2. Severe mental disorders；
•3. A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
•4. History of allogeneic stem cell transplantation；
•5. Heart disease with grade III-IV heart failure \[NYHA classification\], myocardial infarction, angioplasty or stenting, unstable angina or other heart diseases with prominent clinical symptoms within one year before admission；
•6. Subjects with any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, bile drainage tube or pleura/peritoneum/pericardium catheter), should be excluded. (Special central venous catheter is allowed)；
•7. Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis；
•8. Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS；
•9. Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg；
+9 more criteria

Locations (1)

Department of Hematology, Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

May 1, 2020

Primary Completion Date

May 1, 2021

Completion Date

May 1, 2023

Last Updated

March 11, 2020

Enrollment

ESTIMATED participants

Conditions

B-cell Lymphoma RefractoryB-cell Lymphoma Recurrent

Interventions

CD19 and CD22 targeted CAR-T cells

BIOLOGICAL

Contacts

Xi Zhang, MD phD

CONTACT

13808310064 zhangxxi@sina.com

Ruihao Huang

CONTACT

18984398751 1169731117@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CD19 and CD22 Dual-targeted CAR-T Cells for Relapsed or Refractory B-NHL

Inclusion Criteria

Exclusion Criteria

Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma

Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation

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