Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02656147
• Other study ID #: Doing-004
• Status: Not yet recruiting
• Phase: Phase 1
• First received: January 12, 2016
• Last updated: September 1, 2017
• Start date: October 2017
• Est. completion date: April 2020

Study information

• Verified date: September 2017
• Source: Beijing Doing Biomedical Co., Ltd.
• Contact: Xie yanyun, master
• Phone: +8615601041145
• Email: yanyun_xie[@]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 allogeneic γδT-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) γδT-cells (CD19 CAR γδT-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR γδT-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR γδT-cells in patients with high risk relapsed CD19+ malignancies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: April 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.

2. KPS>60.

3. Life expectancy>3 months.

4. Gender unlimited, age from 18 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 infusion.

Exclusion Criteria:

1. KPS<50.

2. Patients are allergic to cytokines.

3. Central nervous system leukemia within 28 days.

4. Uncontrolled active infection.

5. Acute or chronic GVHD.

6. Treated with T cell inhibitor.

7. Pregnancy and nursing females.

8. HIV/HBV/HCV Infection.

9. Other situations we think improper for the research.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Beijing DOING Biomedical Co., Ltd	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Doing Biomedical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of each patient.	Adverse events of each patient will be recorded and analysed.	3 years
Secondary	Survival time of Anti-CD19 CAR ?dT cells in vivo.	PCR will be applied to analyse the survival time of Anti-CD19 CAR ?dT cells in vivo.	3 years
Secondary	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
Secondary	Maximum tolerated dose (MTD) of CD19 targeted CAR ?dT cells.	Maximum tolerated dose (MTD) of CD19 targeted CAR ?dT cells.	4 weeks