Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

Phase 1

• Conditions: Non Hodgkin Lymphoma
• Interventions: Biological: IM19; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT03528421
• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief Summary

n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.

Detailed Description

1. Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups.

2. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-17
• Study Start: 2018-05-22
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-16
• Primary Completion: 2020-04
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IM19 CAR-T cells	IM19	3\*10\^5/kg，1\*10\^6/kg，3\*10\^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days
IM19 CAR-T cells	Fludarabine	3\*10\^5/kg，1\*10\^6/kg，3\*10\^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days
IM19 CAR-T cells	Cyclophosphamide	3\*10\^5/kg，1\*10\^6/kg，3\*10\^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days

Primary Outcome Measures

Name	Time	Method
Occurrence of study related adverse events	2 years	\>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

Secondary Outcome Measures

Name	Time	Method
Overall response rate	2 years	(1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014)

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China