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Sequential Radiotherapy With CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies With Extramedullary Lesions

Primary Purpose

Hematological Malignancies

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CAR-T cells

About this trial

This is an interventional treatment trial for Hematological Malignancies focused on measuring radiotherapy, CAR-T, extramedullary lesions, relapsed and refractory

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age≥15 years old; Relapsed and refractory hematological malignancies with extramedullary lesions, mainly including B-cell non Hodgkin's lymphoma, multiple myeloma, acute lymphoblastic leukemia, etc; Flow cytometry or pathological biopsy confirmed that tumor cells have potential therapeutic targets for Car-T cells; PET-CT confirmed that the extramedullary lesions were located in a single radiotherapy region; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Sites / Locations

The First Hospital of Zhejiang Medical Colleage Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiotherapy and CAR-T therapy

Arm Description

sequential radiotherapy and CAR-T cell therapy

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Incidence of treatment-emergent adverse events (TEAEs)

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

Secondary Outcome Measures

Complete Remission Rate

Complete Remission Rate after CAR-T cell therapy

Overall survival (OS)

From the first infusion of CD19 CAR-T cells to death or the last visit

Disease-free survival (DFS)

From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit

Quality of life

Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

Full Information

NCT ID

NCT04790747

First Posted

March 8, 2021

Last Updated

March 8, 2021

Sponsor

Zhejiang University

Collaborators

Yake Biotechnology Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04790747

Brief Title

Sequential Radiotherapy With CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies With Extramedullary Lesions

Official Title

Clinical Trial for the Safety and Efficacy of Sequential Radiotherapy With CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies With Extramedullary Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 2021 (Anticipated)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

Yake Biotechnology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Clinical trial for the safety and efficacy of sequential radiotherapy with CAR-T cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions

Detailed Description

This is a prospective, single arm study. To evaluate the safety and efficacy of sequential radiotherapy with CAR-T cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

6. Conditions and Keywords

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

Hematological Malignancies

Keywords

radiotherapy, CAR-T, extramedullary lesions, relapsed and refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

radiotherapy and CAR-T therapy

Arm Type

Experimental

Arm Description

sequential radiotherapy and CAR-T cell therapy

Intervention Type

Drug

Intervention Name(s)

CAR-T cells

Intervention Description

Each subject receives sequential radiotherapy and CAR-T cells by intravenous infusion

Primary Outcome Measure Information:

Title

Dose-limiting toxicity (DLT)

Description

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time Frame

Baseline up to 28 days after CAR-T cells infusion

Title

Incidence of treatment-emergent adverse events (TEAEs)

Description

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

Time Frame

Up to 2 years after CAR-T cells infusion

Secondary Outcome Measure Information:

Title

Complete Remission Rate

Description

Complete Remission Rate after CAR-T cell therapy

Time Frame

up to 28 days after CAR-T cells infusion

Title

Overall survival (OS)

Description

From the first infusion of CD19 CAR-T cells to death or the last visit

Time Frame

Up to 2 years after CAR-T cells infusion

Title

Disease-free survival (DFS)

Description

From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit

Time Frame

Up to 2 years after CAR-T cells infusion

Title

Quality of life

Description

Time Frame

At Baseline, Month 1, 3, 6, 9 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age≥15 years old; Relapsed and refractory hematological malignancies with extramedullary lesions, mainly including B-cell non Hodgkin's lymphoma, multiple myeloma, acute lymphoblastic leukemia, etc; Flow cytometry or pathological biopsy confirmed that tumor cells have potential therapeutic targets for Car-T cells; PET-CT confirmed that the extramedullary lesions were located in a single radiotherapy region; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Central Contact Person:

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

He Huang, PhD

Phone

86-13605714822

huanghe@zju.edu.cn

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

Mingming Zhang, PhD

Phone

86-13656674208

mingmingzhang@zju.edu.cn

Facility Information:

Facility Name

The First Hospital of Zhejiang Medical Colleage Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

He Huang, PhD

Phone

86-13605714822

hehuangyu@126.com

First Name & Middle Initial & Last Name & Degree

Mingming Zhang, PhD

Phone

86-13656674208

mingmingzhang@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sequential Radiotherapy With CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies With Extramedullary Lesions

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