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

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

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

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Biological: IM19 CAR-T; Drug: fludarabine and cyclophosphamide

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Hebei Yanda Ludaopei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: IM19; Drug: fludarabine and cyclophosphamide; Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days; Other Names: FC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Investigators: Principal Investigator: PEIHUA LU, MD, Hebei Yanda Ludaopei Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Fludarabine
• Other Study ID Numbers: YMCART201702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No