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Completed

NCT Number: NCT03173417

Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.

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Key information

Age range

3 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hebei Yanda Ludaopei Hospital

Beijing, China

About this study

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia and determine the best dosage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with CD19+ Refractory or Relapsed B-ALL(At least 2 prior combination chemotherapy regimens)
  • To be aged 3 to 75 years
  • Blast in blood ≤ 30%
  • ECOG score ≤2
  • Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
  • Voluntary participation in the clinical trials and sign the informed consent.

Exclusion criteria

  • Intracranial hypertension or unconsciousness
  • Respiratory failure
  • CD19 negative
  • Disseminated intravascular coagulation
  • ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x normal value
  • Hematosepsis or Uncontrolled active infection
  • Uncontrolled diabetes
  • Abalienation;
  • WHO Sscore >3
  • Patients in pregnancy or breast-feeding period
  • Previously treatment with any gene therapy products
  • Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
  • Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Treatment and study plan

IM19 CAR-T

Biological

T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor

Other names: IM19

fludarabine and cyclophosphamide

Drug

Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days

Other names: FC

Primary outcomes

  1. Occurrence of study related adverse events

    Time frame: 2 years

    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

Secondary outcomes

  1. Overall response rate

    Time frame: 2 years

    An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry

Sponsors and collaborators

Lead sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Industry

Registry information

Official study title

Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2017
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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