Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma.

NCT04639739 | Unknown Early Phase 1

• 1 other identifier: CAR NK for NHL
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 limitations of CAR-T cells, the consuming manufacturing time and expensive price exclude the majority of patients. therefore, we designed this trial to manifest the safety and efficacy of anti-CD19 CAR NK cell therapy in non-Hodgkin lymphoma

Conditions

NHL

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLTs)

  To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma

  within 4 weeks after infusion

• Incidence and severity of AEs and SAEs

  To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma

  Up to 24 months

Secondary Outcomes (3)

• The overall response rate(ORR)

  1 and 3 months after infusion

• progression-free survival (PFS)

  1, 3, 6, 12 and 24 months after infusion

• overall survival(OS)

  1, 3, 6, 12 and 24 months after infusion

Study Arms (1)

anti-CD19 CAR NK cells

EXPERIMENTAL

The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determined optimal dosage.

Biological: anti-CD19 CAR NK

Interventions

anti-CD19 CAR NK BIOLOGICAL

2×106 /kg、6×106 /kg、2×107/kg Treatment follows a lymphodepletion, the recommended chemotherapy regimen consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) for 3 days prior to cell infusion，the actual regiment is determined by the statue of patients.

anti-CD19 CAR NK cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Any of the following points shall be deemed as no entry into this study：
• 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)；
• Severe mental disorders；
• A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
• History of allogeneic stem cell transplantation；
• 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；
• 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)；
• Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis；
• Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS；
• Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg；
• Active infection requiring systematic treatment within 2 weeks before single collection；
• Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy；
• History of autoimmune diseases (e.g. Crohn disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end-organ damage or require systemic immunosuppressive medications or systemic disease modifying drugs in the past 2 years；
• Presence of pulmonary fibrosis；
• Subjects who have received other clinical trial treatment within 4 weeks before participating in this trial should be excluded. Or the signing date of informed consent is within 5 half-lives of the last application of another clinical trial (whichever is longer)；

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• Chongqing Precision Biotech Co., Ltd: collaborator

Study Sites (1)

Department of Hematology, Xinqiao Hospital

Chongqing, Chongqing Municipality, 400037, China

Location

Study Officials

• Xi Zhang

  Xinqiao Hospital of Chongqing

  STUDY CHAIR

Central Study Contacts

Xi Zhang, MD phD

CONTACT

13808310064; zhangxxi@sina.com

Ruihao Huang

CONTACT

18984398751; 1169731117@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef of Hematology Department

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 20, 2020
• Study Start: December 17, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

CN (1)