a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B Cell Lymphoma

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma

Study Overview

• Status: Recruiting
• Conditions: B Cell Lymphoma
• Intervention / Treatment: Biological: CD19 and CD22 targeted prime CAR- T cells

Detailed Description

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.

There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Yunnnan
    • Kunming, Yunnnan, China
      • Recruiting
      • 920th Hospital of Joint Logistics Support Force
      • Contact: Sanbin Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed written informed consent

2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane CD19 or CD22 expression
4. All genders ages: 2 to 75 years
5. The expect time of survive is above 3 months;
6. KPS>60
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
12. With single or venous blood collection standards, and no other cell collection contraindications;
13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prime CAR- T cells; Patients will be be treated with CD19 and CD22 prime CAR- T cells	Biological: CD19 and CD22 targeted prime CAR- T cells; A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events that related to treatment	Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)	2 years
The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma	The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of prime CAR-T cells in bone marrow	Determine the rate of prime CAR-T cells in bone marrow by means of flow cytometry	2 years
Rate of prime CAR-T cells in peripheral blood	Determine the rate of prime CAR-T cells in peripheral blood by means of flow cytometry	2 years
Quantity of prime CAR copies in bone marrow	Determine the quantity of prime CAR copies in bone marrow by qPCR	2 years
Quantity of prime CAR copies in peripheral blood	Determine the quantity of prime CAR copies in peripheral blood by qPCR	2 years
Rate of CD19 and CD22 positive cells in Bone marrow	Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry	1 years
Levels of IL-6 in Serum	Serological determination of IL-6	3 months
Levels of IL-10 in Serum	Serological determination of IL-10	3 months
Levels of TNF-α in Serum	Serological determination of TNF-α	3 months
Levels of CRP in Serum	Serological determination of CRP	3 months
Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma	DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)	2 years
Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma	PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)	2 years
Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma	OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)	2 years

Collaborators and Investigators

• Sponsor: Chongqing Precision Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: CAR-T; CD19; CD22
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: PBC026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No