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

• Sponsor: Beijing Doing Biomedical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT02546739
• Collaborator: The First Hospital of Jilin University (Other), Hebei Yanda Ludaopei Hospital (Other)
• Enrollment: 100
• Locations: 12
• Arms: 3
• Anticipated Duration (Months): 24
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.3

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 autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.

Condition or Disease	Intervention/Treatment	Phase
Leukemia; Lymphoma	Biological: Anti-CD19-CAR	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) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. 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+ malignancies.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

   Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Secondary Outcome Measures

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

   To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.

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 T cells. [4 weeks]

   Maximum tolerated dose (MTD) of CD19 targeted CAR T 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 trial.

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 Cancer Hospital	Beijing	Beijing	China	100142
2	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120
3	Hebei Yanda Ludaopei Hospital	Sanhe	Hebei	China	065200
4	First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan	China	471003
5	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
6	Huai'An First People'S Hospital	Huaian	Jiangsu	China	223300
7	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China	210008
8	First Hospital of Jilin University	Changchun	Jilin	China	130021
9	Shanxi Dayi Hospital	Taiyuan	Shanxi	China	030000
10	Tianjin people's hospital	Tianjin	Tianjin	China	300121
11	Hangzhou Cancer Hospital	Hangzhou	Zhejiang	China	310002
12	Beijing DOING Biomedical Co., Ltd	Beijing		China	100021

Sponsors and Collaborators

• Beijing Doing Biomedical Co., Ltd.
• The First Hospital of Jilin University
• Hebei Yanda Ludaopei Hospital

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: NCT02546739
• Other Study ID Numbers: Doing-002
• First Posted: Sep 11, 2015
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• 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 T
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Jan 26, 2021