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

• Sponsor: Beijing Doing Biomedical Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02656147
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia; Lymphoma	Biological: Anti-CD19-CAR γδT	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of γδT Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
• Anticipated Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: 1 Acute lymphoblastic leukemia treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.	Biological: Anti-CD19-CAR γδT; Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
Experimental: Experimental: 2 Chronic lymphoblastic leukemia with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.	Biological: Anti-CD19-CAR γδT; Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
Experimental: Experimental: 3 Non-hodgkin lymphoma treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.	Biological: Anti-CD19-CAR γδT; Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)

Outcome Measures

Primary Outcome Measures

1. Adverse events of each patient. [3 years]

   Adverse events of each patient will be recorded and analysed.

Secondary Outcome Measures

1. Survival time of Anti-CD19 CAR γδT cells in vivo. [3 years]

   PCR will be applied to analyse the survival time of Anti-CD19 CAR γδT cells in vivo.

2. Antitumor Effects [Every 3 months post treatment up to 24 months]

   Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

3. Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells. [4 weeks]

   Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing DOING Biomedical Co., Ltd	Beijing		China	100021

Sponsors and Collaborators

• Beijing Doing Biomedical Co., Ltd.

Investigators

• Study Chair: Li gangyi, master, Beijing Doing Biomedical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Doing Biomedical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02656147
• Other Study ID Numbers: Doing-004
• First Posted: Jan 14, 2016
• Last Update Posted: Sep 5, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Beijing Doing Biomedical Co., Ltd.: Leukemia; Lymphoma; CAR γδT
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Sep 5, 2017