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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03173417
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Immunochina Medical Science & Technology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Leukemia Biological: IM19 CAR-T Drug: fludarabine and cyclophosphamide Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IM19 CART
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.
Biological: IM19 CAR-T
T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor
Other Name: IM19

Drug: fludarabine and cyclophosphamide
Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
Other Name: FC




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with CD19+ Refractory or Relapsed B-ALL(At least 2 prior combination chemotherapy regimens)
  2. To be aged 3 to 75 years
  3. Blast in blood ≤ 30%
  4. ECOG score ≤2
  5. 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.
  6. Voluntary participation in the clinical trials and sign the informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173417


Locations
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China
Hebei Yanda Ludaopei Hospital
Beijing, China
Sponsors and Collaborators
Beijing Immunochina Medical Science & Technology Co., Ltd.
Investigators
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Principal Investigator: PEIHUA LU, MD Hebei Yanda Ludaopei Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beijing Immunochina Medical Science & Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03173417    
Other Study ID Numbers: YMCART201702
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists