Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia

Leukemia Clinical Trial

Official title:

Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04100187
• Other study ID #: Kece-1
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2022
• Source: Kecellitics Biotech Company Ltd
• Contact: Li xiangqun, DOCTOR
• Phone: 086-15712867910
• Email: xiangqun_li[@]doingtimes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.

Description:

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ Leukemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR Tcells.

Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ Leukemia

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Relapsed or refractory B cell Leukemia.

2. KPS>60.

3. Life expectancy>3 months.

4. Gender unlimited, age from 2 years to 70 years.

5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.

6. Patients who have failed at least one line of a standard treatment.

7. No serious mental disorder.

8. Patients must have adequate cardiac function(no cardiac disease, LVEF=40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr=133umol/L).

9. No other serious diseases(autoimmune disease, immunodeficiency etc.).

10. No other tumors.

11. Patients volunteer to participate in the research.

12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial

Exclusion Criteria:

1. KPS<50.

2. Patients are allergic to cytokines.

3. Uncontrolled active infection.

4. Acute or chronic GVHD.

5. Treated with T cell inhibitor.

6. Pregnancy and nursing females.

7. HIV/HBV/HCV Infection.

8. Other situations we think improper for the research.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell

Intervention

Biological:
• Anti-CD19-CAR
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kecellitics Biotech Company Ltd	Hebei Yanda Ludaopei Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of each patient	Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	3 years
Primary	Survival time of Anti-CD19 CAR T cells in vivo	To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.	3 years
Primary	Antitumor Effects	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.	Every 3 months post treatment up to 24 months
Primary	Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.	Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.	4 weeks