Safety and Efficacy of CD19-Targeted CAR-T Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma

STATUS

Recruiting
participants needed

40
sponsor

Chongqing Precision Biotech Co., Ltd

Send

Updated on 19 February 2024

See if I qualify

psychiatric disorder

remission

renal function

ejection fraction

stem cell transplantation

chronic lymphocytic leukemia

cell transplantation

lymphoma

induction chemotherapy

oxygen saturation

cancer chemotherapy

leukemia

renal function test

alt/ast

mental illness

cell therapy

cellular therapy

Summary

This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.

Description

There are limited options for treatment of relapse/refractory CD19+ B Cell Leukemia and Lymphoma. CD19 is expressed on most CD19+ B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Details

Condition	Leukemia, B-Cell, Lymphoma, leukemia, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia
Age	3years - 75years
Treatment	CD19 CAR-T cells
Clinical Study Identifier	NCT04271800
Sponsor	Chongqing Precision Biotech Co., Ltd
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed written informed consent
	Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions
	Failed to standard chemotherapy regimens
	Relapse after complete remission, high-risk and / or refractory patients
	Relapse after hematopoietic stem cell transplantation
	For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)
	Evidence for cell membrane CD19 expression
	All genders, ages: 3 to 75 years
	The expect time of survive is above 12 weeks
	KPS60
	No serious mental disorders
	Left ventricular ejection fraction 50%
	Sufficient hepatic function defined by ALT/AST3 x ULN and bilirubin2 x ULN
	Sufficient renal function defined by creatinine clearance2 x ULN
	Sufficient pulmonary function defined by indoor oxygen saturation92%
	With single or venous blood collection standards, and no other cell collection contraindications
	Ability and willingness to adhere to the study visit schedule and all protocol requirements
Exclusion Criteria
	Have received CAR-T therapy or other genetically modified cell therapy before screening
	Participated in other clinical research within 1 month before screening
	Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment
	Live attenuated vaccine within 4 weeks before screening
	Convulsion or stoke within past 6 months
	Previous history of other malignancy
	Presence of uncontrolled active infection
	Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive
	Pregnant or breasting-feeding women
	Any situation that investigators regard not suitable for attending in this study or may affect the data analysis

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

stem cell transplantation

chronic lymphocytic leukemia

cell transplantation

lymphoma

induction chemotherapy

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

Safety and Efficacy of CD19-Targeted CAR-T Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma