Efficacy and Safety Evaluation of IM19 CAR-T Cell Therapy for MRD+ After Transplantation

NCT04336501 | Unknown

• 1 other identifier: YMCART20190423
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• ORR at 6 month

  Objective response at 6 month

  6 months

Study Arms (1)

IM19 CAR-T group

EXPERIMENTAL

Subject will be treated with IM19 car-t cells

Biological: IM19 CAR-T

Interventions

IM19 CAR-T BIOLOGICAL

All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later

IM19 CAR-T group

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To be aged 3 to 65 years
• It was consistent with the diagnosis of CD19+ B-All with MRD+ in allo- hsct transplantation
• The immunotyping was determined to be CD19+ B-All
• The T lymphocytes in the subjects were 100% donor T lymphocytes
• No chemotherapy or antibody treatment was received 2 weeks before cell therapy
• The subjects had no pulmonary active infection
• Blood oxygen saturation at the fingertips ≥ 92%
• Estimated survival of \>3 months
• ECOG physical condition level 0\~1

You may not qualify if:

• Unwilling to accept IM19 CAR-T cell therapy, do not agree to signInformed consent of subject
• Subjects are allergic to the components of cellular products
• Total serum bilirubin ≥ 2.0mg/dl、Serum albumin \< 35g/L、ALT and AST were more than 3 times of the upper limit of the normal range. Blood creatinine ≥ 2.0mg/dl;Platelet \< 20 x 109 / L
• Subjects had activity level II-IV aGVHD, or activityModerate to severe cGVHD
• The subjects had a severe failure to control the infection
• Subject with known central nervous system leukemia (CNS2 or CNS3)
• Subjects were treated with CAR T cells or DLT after transplantation
• The subjects developed bone marrow failure syndrome after allo-hsct transplantation
• The subjects had previously received other gene treatments
• The subjects had a history of alcohol, drug use or mental illness
• Subjects were enrolled in any other clinical investigator within 1 month prior to screening
• Female subjects: 1) were pregnant/lactating, or 2) had a pregnancy plan during the study period,Or 3) fertile and unable to use effective contraception
• The researchers believe there are other conditions that may not be appropriate for the study

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

Peking University people's hospita

Beijing, Beijing Municipality, 000000, China

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• xiang yu zhao, MD

  Peking University people's hospita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiang yu zhao, MD

CONTACT

13520122292; xyz80421@126.com

zheng li xu

CONTACT

13501338951

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)