Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma

NCT04626908 | Unknown Phase 1 DMC

• 1 other identifier: GC022F-ZhejiangU
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma

Conditions

Relapsed and Refractory; Lymphoid Hematological Malignancies

Keywords

lymphoid hematological malignancies; CAR-T cell therapy; CD19; CD22

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Proportion of patients with dose limiting toxicity (DLT) after cell infusion

  Within 28 days after cell infusion

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  24 months after cell infusion

Secondary Outcomes (4)

• Overall response rate(ORR)

  Month 1,3,6,12,18and 24

• Progression-free survival (PFS)

  Month 6,12,18and 24

• Overall survival (OS)

  Month 6,12,18and 24

• Duration of response(DOR)

  Month 6,12,18and 24

Study Arms (1)

Administration of GC022F CAR-T cells

EXPERIMENTAL

Each subject receive GC022F CAR T-cells by intravenous infusion

Drug: GC022F CAR-T cells

Interventions

GC022F CAR-T cells DRUG

Each subject receive GC022F CAR-T cells by intravenous infusion

Also known as: GC022F CAR-T cells injection

Administration of GC022F CAR-T cells

Eligibility Criteria

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

You may qualify if:

• Male or female, 18-75 years old (including the threshold value);
• Histologically confirmed as diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), or primary mediastinal B-cell lymphoma (PMBCL) :
• i. Refractory B-NHL: PD was the optimal response to standard first-line treatment (those with intolerance to first-line treatment were not included in this study); Or SD after at least 4 courses of first-line treatment, and the DURATION of SD shall not exceed 6 months after the last treatment; Or the subjects' best response to the last treatment of second-line or above treatment is PD, or SD after at least 2 courses of second-line or above treatment, and the SD maintenance time is not more than 6 months; Or:
• ii. Relapsed B-NHL: after standard systemic treatment and complete remission after second-line treatment, the disease recurred as certified by histopathology, or the recurrence as confirmed by histopathology within 1 year after autologous hematopoietic stem cell transplantation (not limited by previous treatment methods);
• iii. Patients with INVERt follicular lymphoma must receive chemotherapy prior to transformation and meet the above definition of recurrent or refractory after transformation;
• according to Lugano treatment response standard (2014 version), there should be at least one evaluable tumor lesion: the longest diameter of the injunctional lesion was \> 1.5cm, and the longest diameter of the injunctional lesion was b\> 1.0cm;
• Positive expression of CD19 and CD22 in biopsy sections of tumor tissues;
• Patients who have failed or relapsed after single-target CAR-T therapy may also be enrolled.
• Prior to the study, the approved anti-B-NHL treatment, such as systemic chemotherapy, general radiotherapy and immunotherapy, has been completed for at least 2 weeks;
• ECOG≤1；
• Expected survival ≥3 months;
• Absolute count of neutrophils ≥ 1×109/L;
• Platelet count ≥50×109/L;
• Absolute lymphocyte count ≥1×108/L;
• Adequate organ function reserve:

You may not qualify if:

• Other tumors (except cured non melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast ductal carcinoma in situ, or other malignant tumors with complete remission for more than 5 years);
• Persons with severe mental disorders;
• A history of hereditary diseases such as Fanconi anemia, Schrader syndrome, Costerman syndrome, or any other known bone marrow failure syndrome;
• A history of allogeneic stem cell transplantation;
• Heart disease with grade III-IV heart failure \[New York Heart Association (NYHA) classification\] or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically significant cardiac conditions within the year prior to enrollment;
• The presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, bile drainage tube or pleural/peritoneal/pericardial catheter), allowing the use of a dedicated central venous catheter;
• Subjects with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastasis;
• A history or disease of the central nervous system, such as seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
• The results of any of the following virology-ELISA tests were positive: HIV antibody, HCV antibody, TPPA, hepatitis B surface antigen;
• There were active infections requiring systematic treatment within 2 weeks before single collection;
• Persons with a known severe allergic reaction to cyclophosphamide or fludarabine, or with an allergic constitution;
• A history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has caused injury to the terminal organs or requires systemic immunosuppressive/disease-modulating drugs within the past 2 years;
• Pulmonary fibrosis is present;
• Has received treatment in another clinical trial within 4 weeks prior to participation in this trial, or the date of signing of the informed consent is within 5 half-lives (whichever is longer) of the last medication used in the last other clinical trial;
• Poor compliance due to physiological, family, social, geographical and other factors, unable to comply with the research program and follow-up plan;

Sponsors & Collaborators

• He Huang: lead
• Gracell Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

He Huang, MD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

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

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 13, 2020
• Study Start: November 20, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)