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ThisCART19A for B-NHL Relapsed After Auto-CAR T

Primary Purpose

CAR, B Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ThisCART19A with Dose Level 1
ThisCART19A with Dose Level 2
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CAR focused on measuring Universal CAR-T

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Voluntarily sign a documented IRB-approved ICF prior to any screening procedure; Gender not restricted, 18 years ≤ age ≤ 75 years; Subjects with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma; Life expectancy ≥ 12 weeks at the time of enrollment; Eastern Cooperative Oncology Group performance status score of 0 or 1; At least one measurable lesion to be assessed, with any nodal lesion > 15mm in LDi (longest diameter) and any extranodal lesion > 10mm in LDi; Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: Adequate marrow function for lymphodepletion chemotherapy: 14 days before enrollment, absolute neutrophil count (ANC) ≥ 1×10^9/L, platelet count ≥ 30×10^9/L, hemoglobin ≥ 80 g/L without blood transfusion; Creatinine clearance ≥ 30 ml/min according to the Cockcroft-Gault formula, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × the upper limit of normal (ULN), total bilirubin ≤ 2×ULN (Subjects with Gilbert syndrome or liver involvement may be enrolled if their total bilirubin is ≤ 3×ULN); Pulmonary function: Baseline oxygen saturation (SaO2) ≥ 92% on room air; Cardiac function:left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography. CD19-positive lymphoma confirmed on a biopsy during screening. Exclusion Criteria: Allergic to preconditioning measures in the trial. Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.) Severe active infection (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted). Pulmonary embolism (PE) within 3 months prior to enrollment. Intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases assessed by the investigator prior to enrollment. Gastrointestinal involvement at risk of active bleeding. Massive pericardial effusion, symptomatic thoracic or abdominal effusion. Presence of CNS involvement (both primary and secondary) at screening confirmed by imaging or CSF testing. Active hepatitis B virus (serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Patients with HBV-DNA < 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) Less than 100 days after allogeneic hematopoietic stem cell transplantation. Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion chemotherapy. (Patients vaccinated with SARS-COV19 vaccine or inactivated; live/non-live adjuvant vaccines can be enrolled.) Under treatment for graft versus host disease (GvHD). (GvHD cured subjects who had stopped immunosuppressive drugs for at least 1 month can be enrolled.) Female subjects who are pregnant, breastfeeding or planning for pregnancy within 1 year after CAR-T cell infusion, or male subjects whose partners are planning for pregnancy within 1 year after CAR-T cell infusion; Any conditions that would, in the investigator's assessment, increase risks in patients or interfere with the outcomes of the trial.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Level 1

Dose Level 2

Arm Description

ThisCART19A,2×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused)

ThisCART19A,3×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused)

Outcomes

Primary Outcome Measures

BOR
Best Overall Response Rate

Secondary Outcome Measures

ORR
Objective response rate
CR
Complete response rate
TTR
Time to response
DOR
Duration of response
EFS
Event-free survival
PFS
Progression-free survival
OS
Overall survival

Full Information

First Posted
December 27, 2022
Last Updated
January 18, 2023
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Fundamenta Therapeutics, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05691153
Brief Title
ThisCART19A for B-NHL Relapsed After Auto-CAR T
Official Title
A Single-center, Dose Selection Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Auto-CAR T Relapsed B-cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Fundamenta Therapeutics, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.
Detailed Description
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma. The study will identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CAR, B Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma
Keywords
Universal CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
ThisCART19A,2×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused)
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
ThisCART19A,3×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused)
Intervention Type
Drug
Intervention Name(s)
ThisCART19A with Dose Level 1
Other Intervention Name(s)
ThisCART19A with 2×10^6 cells/kg
Intervention Description
ThisCART19A,2×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused), after the lymphodepletion conditioning of fludarabine, CTX and VP-16
Intervention Type
Drug
Intervention Name(s)
ThisCART19A with Dose Level 2
Other Intervention Name(s)
ThisCART19A with 3×10^6 cells/kg
Intervention Description
ThisCART19A,3×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused), after the lymphodepletion conditioning of fludarabine, CTX and VP-16
Primary Outcome Measure Information:
Title
BOR
Description
Best Overall Response Rate
Time Frame
3 month
Secondary Outcome Measure Information:
Title
ORR
Description
Objective response rate
Time Frame
2 year
Title
CR
Description
Complete response rate
Time Frame
2 year
Title
TTR
Description
Time to response
Time Frame
3 month
Title
DOR
Description
Duration of response
Time Frame
2 year
Title
EFS
Description
Event-free survival
Time Frame
2 year
Title
PFS
Description
Progression-free survival
Time Frame
2 year
Title
OS
Description
Overall survival
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntarily sign a documented IRB-approved ICF prior to any screening procedure; Gender not restricted, 18 years ≤ age ≤ 75 years; Subjects with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma; Life expectancy ≥ 12 weeks at the time of enrollment; Eastern Cooperative Oncology Group performance status score of 0 or 1; At least one measurable lesion to be assessed, with any nodal lesion > 15mm in LDi (longest diameter) and any extranodal lesion > 10mm in LDi; Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: Adequate marrow function for lymphodepletion chemotherapy: 14 days before enrollment, absolute neutrophil count (ANC) ≥ 1×10^9/L, platelet count ≥ 30×10^9/L, hemoglobin ≥ 80 g/L without blood transfusion; Creatinine clearance ≥ 30 ml/min according to the Cockcroft-Gault formula, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × the upper limit of normal (ULN), total bilirubin ≤ 2×ULN (Subjects with Gilbert syndrome or liver involvement may be enrolled if their total bilirubin is ≤ 3×ULN); Pulmonary function: Baseline oxygen saturation (SaO2) ≥ 92% on room air; Cardiac function:left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography. CD19-positive lymphoma confirmed on a biopsy during screening. Exclusion Criteria: Allergic to preconditioning measures in the trial. Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.) Severe active infection (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted). Pulmonary embolism (PE) within 3 months prior to enrollment. Intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases assessed by the investigator prior to enrollment. Gastrointestinal involvement at risk of active bleeding. Massive pericardial effusion, symptomatic thoracic or abdominal effusion. Presence of CNS involvement (both primary and secondary) at screening confirmed by imaging or CSF testing. Active hepatitis B virus (serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Patients with HBV-DNA < 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) Less than 100 days after allogeneic hematopoietic stem cell transplantation. Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion chemotherapy. (Patients vaccinated with SARS-COV19 vaccine or inactivated; live/non-live adjuvant vaccines can be enrolled.) Under treatment for graft versus host disease (GvHD). (GvHD cured subjects who had stopped immunosuppressive drugs for at least 1 month can be enrolled.) Female subjects who are pregnant, breastfeeding or planning for pregnancy within 1 year after CAR-T cell infusion, or male subjects whose partners are planning for pregnancy within 1 year after CAR-T cell infusion; Any conditions that would, in the investigator's assessment, increase risks in patients or interfere with the outcomes of the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Chen, M.D., Ph.D.
Phone
+86-512-67781856
Email
drchenjia@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, Ph.D.
Phone
+86-18662604088
Email
jli@ctigen.com
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Depei Wu
Phone
+86 13951102021
Email
drwudepei@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ThisCART19A for B-NHL Relapsed After Auto-CAR T

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