CD19 and BCMA Targeted Fast Dual CAR-T for CD19+ Refractory/Relapsed B-NHL

NCT04877080 | Withdrawn Phase 1

• 1 other identifier: 211
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single arm, open-label, single-center prospective study to determine the safety and efficacy of Fast Dual CAR-T cells in patients diagnosed with CD19+ refractory/relapsed B cell non-Hodgkinlymphoma (R/R B-NHL).

Conditions

B-cell Lymphoma

Keywords

Fast; CAR-T; CD19; B-NHL

Outcome Measures

Primary Outcomes (1)

• Incidence of AE after Fast Dual CAR-T infusion

  Incidence of adverse events after Fast Dual CAR-T infusion

  up to 24 weeks after Fast Dual CAR-T infusion

Secondary Outcomes (7)

• ORR rate

  12 weeks, 24 weeks after Fast Dual CAR-T infusion

• PFS

  12 weeks, 24 weeks after Fast Dual CAR-T infusion

• OS

  12 weeks, 24 weeks after Fast Dual CAR-T infusion

• Change of CAR Copies

  Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after Fast Dual CAR-T infusion

• Change of CAR-T cell counts

  Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after Fast Dual CAR-T infusion

Study Arms (1)

Fast Dual CAR-T treatment

EXPERIMENTAL

CD19+ R/R B-NHL patients be treated with a single dose of Fast Dual CAR-T cells. Total dose of (1-5)\*10E5/kg cells will be administered at Day 0.

Biological: Fast Dual CAR-T Injection

Interventions

Fast Dual CAR-T Injection BIOLOGICAL

Fast Dual CAR-T injection is a autologous dual CAR-T targeted CD19 and BCMA. A single infusion of CART cells will be administered intravenously.

Fast Dual CAR-T treatment

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed: Diffuse Large B Cell Lymphoma (DLBCL), Transformation Follicular Lymphoma (TFL), Primary Mediastinal Large B Cell Lymphoma (PMBCL) and Mantle Cell Lymphoma (MCL), High-Grade B Cell Lymphoma (HGBL);
• Refractory B-NHL: PD as the best response to normative first-line therapy (intolerance of first-line therapy is not included in this study) or SD as the best response to at least 4 courses of first-line therapy with duration no longer than 6 month from last therapy; or PD as the best response to the last therapy of second-line therapy and above,or SD as the best response to at least 2 courses of second-line therapy with duration no longer than 6 month from last therapy, or:
• Relapsed B-NHL: Histopathology confirmed relapse after standard systemic and second-line therapy achieved CR, or histopathologically confirmed relapse within 1 year after autologous hematopoietic stem cell transplantation (Not limited by previous therapy);
• Prior therapy must include anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and an anthracycline;
• For individual with TFL, must have chemotherapy and the conform the above definition of relapse or refractory after transformation;
• According to the 2014 Lugano therapy response standard, there should be at least one measurable tumor focus: the longest diameter of nodular lesions\> 1.5 cm, and the longest diameter of extranodal lesions\> 1.0 cm;
• CD19 positive expression in tumor tissue biopsy;
• Prior to apheresis, approved anti-B-NHL therapys such as systemic chemotherapy, systemic radiotherapy and immunotherapy have been completed for at least 2 weeks;
• Eastern cooperative oncology group (ECOG) performance status of 0 to 1;
• Life expectancy ≥12 weeks;
• Absolute neutrophil count (ANC)≥ 1×10\^9/L;
• Platelet count≥50×10\^9/L;
• Absolute lymphocyte count (ALC)≥1×10\^8/L;
• Adequate organ function defined as:
• Serum ALT/AST ≤2.5 ULN;

You may not qualify if:

• Diagnosis of other malignancy (except for cured non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, ductal carcinoma in situ, or other malignancies that have completely responsed for more than 5 years);
• Severe mental disorders;
• History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome;
• History of allogeneic stem cell transplantation;
• Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstableangina pectoris, or other clinically prominent heart disease within one year before enrollment.
• Have any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, indwelling catheter, bile drainage tube or pleura / peritoneum / pericardial catheter), the use of dedicated central venous catheter is allowed;
• Subjects with CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases;
• History or presence of CNS disorder, including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
• Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA;
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled;
• Allergic subjects or subjects with severe allergic reactions to cyclophosphamide or fludarabine;
• History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years;
• History or diagnosis of pulmonary fibrosis;
• Have received gene therapy or any other CAR-T treatment;
• Have received any other drugs targeting CD19;

Sponsors & Collaborators

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China: lead

MeSH Terms

Conditions

Lymphoma, B-Cell; Fasting

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Sanbin Wang, Doctor

  920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 7, 2021
• Study Start: May 5, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02