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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173417
• Other study ID #: YMCART201702
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 23, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2019
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia

Intervention

Biological:
• IM19 CAR-T
T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor

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

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of study related adverse events	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.	2 years
Secondary	Overall response rate	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	2 years