A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04036019
• Collaborator: Cellular Biomedicine Group Ltd. (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 26.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The study is a single arm, single-center, non-randomized clinical study which is designed to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.

Condition or Disease	Intervention/Treatment	Phase
B Cell Lymphoma	Biological: CD20-directed CAR-T cells	Phase 1

Detailed Description

This study plans to enroll 12 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study Evaluating Safety and Efficacy of CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
• Actual Study Start Date: May 13, 2019
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: C-CAR066 Autologous C-CAR066 administered by intravenous (IV) infusion	Biological: CD20-directed CAR-T cells; Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously; Other Names: C-CAR066

Outcome Measures

Primary Outcome Measures

1. Occurrence of study related adverse events [12 weeks]

   Incidence and severity of Treatment emergent adverse events

Secondary Outcome Measures

1. Overall response rate (ORR) [12weeks, 6months, 12 months]

   Lugano criteria(NHL,2014).

2. DOR [12 months]

   Duration of remission

3. PFS [12 months]

   Progression free survival

4. OS [12weeks, 6months, 12months]

   Overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Volunteered to participate in this study and signed informed consent

2. Age 14-70 years old, male or female

3. Patients with CD20+ DLBCL(including PMBL and according to the NCCN. non Hodgkin's lymphoma Guidelines(2019 version1.0) , at least one measurable lesion(LDi≥ 1.5 cm);

4. r/r patients who received prior CD19 CAR-T therapy；

5. At least one week from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis;

6. No immunosuppressive therapy was used within 1 week before infusion, including but not limited to systemic therapy;

7. No mAb treatment within 2 weeks before infusion

8. LVEF≥ 50% (UCG)

9. No active pulmonary infections, normal pulmonary function and SpO2≥92%

10. No contraindications of apheresis;

11. Expected survival ≥ 3months

12. ECOG score 0 or 1

13. The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell

Exclusion Criteria:

1. Have a history of allergy to cellular products

2. Laboratory criteria: Serum total bilirubin ≥2mg/dl, albumin≤35g/L, AST and ALT ≥5 x ULN, Creatinine≥2.0mg/dl, ANC≤750/uL, Platelets≤ 50x10^9/L

3. Have a hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome ,etc;

4. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction；

5. A history of QT prolongation

6. Patients with central nervous system involvement

7. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics, or intravenous infusion of antibiotics within 1 week prior to cell infusion. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;

8. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;

9. Subjects who are not sterilized have any of the following conditions:

10. are pregnant/lactating; or

11. planned pregnancy during the trial; or

12. being fertile and unable to use effective contraception；

13. The investigators consider that the subject has other conditions that are not suitable for this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai		China	200065

Sponsors and Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine
• Cellular Biomedicine Group Ltd.

Investigators

• Principal Investigator: Aibin Liang, MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aibin Liang，MD，Ph.D., Director，Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine
• ClinicalTrials.gov Identifier: NCT04036019
• Other Study ID Numbers: 05/03-04-009
• First Posted: Jul 29, 2019
• Last Update Posted: Jul 29, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aibin Liang，MD，Ph.D., Director，Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine: B cell lymphoma received prior CD19 CAR-T therapy
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell

Study Results

No Results Posted as of Jul 29, 2019