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Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

Primary Purpose

B-cell Malignancy

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

ThisCART22 cells

About this trial

This is an interventional treatment trial for B-cell Malignancy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-70 years old, no gender and race limited;
Estimated life expectancy > 12 weeks deemed by investigator；
CD22 were positive by histopathology and/or cytology diagnosis；
Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
Relevant indicators for disease or assessment within 4 weeks after the last treatment;
Quality of Life Score (KPS) >50%；
Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
Unsuitable conditions for stem cell transplantation;
Signed informed consent form (ICF).

Exclusion Criteria:

Women in pregnancy or lactation;
In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L;
Abnormal vital signs and failure to cooperate with examination;
Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
Highly allergic constitution or history of severe allergy;
Patients with systemic infection or severe local infection requiring anti-infection treatment;
Patients with severe autoimmune diseases;
Presence of any other conditions that are unsuitable for this study as judged by the investigator.

Sites / Locations

The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ThisCART22 cells injections

Arm Description

In this study, allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies.

Outcomes

Primary Outcome Measures

Treatment related adverse events

Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

Secondary Outcome Measures

Overall Remission Rate (ORR)

Anti-tumor efficacy by 2014 Lugano criteria

Progression free survival time

The interval between administration and disease progression or death

Overall survival time

The interval between administration and death caused by any reason

Event-free survival (EFS)

EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.

Full Information

NCT ID

NCT05106946

First Posted

October 25, 2021

Last Updated

November 9, 2021

Sponsor

Fundamenta Therapeutics, Ltd.

Collaborators

The Affiliated Hospital of Xuzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05106946

Brief Title

Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

Official Title

An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD22(ThisCART22) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 25, 2021 (Actual)

Primary Completion Date

October 25, 2023 (Anticipated)

Study Completion Date

October 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundamenta Therapeutics, Ltd.

Collaborators

The Affiliated Hospital of Xuzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART22 (Allogeneic CAR-T targeting CD22) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Detailed Description

ThisCART22 cell is a non-gene-editing allogeneic CAR-T cell targeting CD22. This study is designed to evaluate the safety and clinical activity of ThisCART22 in patients with CD22 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Malignancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ThisCART22 cells injections

Arm Type

Experimental

Arm Description

In this study, allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies.

Intervention Type

Biological

Intervention Name(s)

ThisCART22 cells

Intervention Description

0.2-60 x 10^6 CAR T cells per kg body weight

Primary Outcome Measure Information:

Title

Treatment related adverse events

Description

Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

Time Frame

90 days post infusion

Secondary Outcome Measure Information:

Title

Overall Remission Rate (ORR)

Description

Anti-tumor efficacy by 2014 Lugano criteria

Time Frame

up to 90 days

Title

Progression free survival time

Description

The interval between administration and disease progression or death

Time Frame

3 years

Title

Overall survival time

Description

The interval between administration and death caused by any reason

Time Frame

3 years

Title

Event-free survival (EFS)

Description

EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-70 years old, no gender and race limited; Estimated life expectancy > 12 weeks deemed by investigator； CD22 were positive by histopathology and/or cytology diagnosis； Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)； Relevant indicators for disease or assessment within 4 weeks after the last treatment; Quality of Life Score (KPS) >50%； Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl; No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy; Unsuitable conditions for stem cell transplantation; Signed informed consent form (ICF). Exclusion Criteria: Women in pregnancy or lactation; In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection； The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L; Abnormal vital signs and failure to cooperate with examination; Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation; Highly allergic constitution or history of severe allergy; Patients with systemic infection or severe local infection requiring anti-infection treatment; Patients with severe autoimmune diseases; Presence of any other conditions that are unsuitable for this study as judged by the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Li, Ph.D

Phone

18662604088

jli@ctigen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhenyu Li, Ph.D

Organizational Affiliation

The Affiliated Hospital of Xuzhou Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

The Affiliated Hospital of Xuzhou Medical University

City

Xuzhou

State/Province

Jiangsu

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhenyu Li

Phone

15950688971

lizhenyumd@163.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

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