Clinical trial NCT03173417: Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)
Official title: Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-01
Enrollment: 177
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Occurrence of study related adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Overall response rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hebei Yanda Ludaopei Hospital
Study officials:
affiliation: Hebei Yanda Ludaopei Hospital
name: PEIHUA LU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen M, Fu M, Wang A, Wu X, Zhen J, Gong M, Zhang X, Yue G, Du Q, Zhao W, Zhao Y, Lu P, Wang H. Cytoplasmic CD79a is a promising biomarker for B lymphoblastic leukemia follow up post CD19 CAR-T therapy. Leuk Lymphoma. 2022 Feb;63(2):426-434. doi: 10.1080/10428194.2021.1980214. Epub 2021 Oct 21.
citation: Zhang X, Lu XA, Yang J, Zhang G, Li J, Song L, Su Y, Shi Y, Zhang M, He J, Song D, Lv F, Li W, Wu Y, Wang H, Liu H, Zhou X, He T, Lu P. Efficacy and safety of anti-CD19 CAR T-cell therapy in 110 patients with B-cell acute lymphoblastic leukemia with high-risk features. Blood Adv. 2020 May 26;4(10):2325-2338. doi: 10.1182/bloodadvances.2020001466.