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

Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03528421

Enrollment

Registered

2018-05-17

Start date

2018-05-22

Completion date

2020-05-31

Last updated

2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Hodgkin Lymphoma

Keywords

CAR-T

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.

Interventions

BIOLOGICALIM19

CAR-T cells

DRUGFludarabine

Two days before cell infusion, all patients will be treated with fludarabine for 3 days

DRUGCyclophosphamide

Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment. 2. Patients must have evaluable disease evidence; 3. Age ≥ 18 years old; 4. The expected life span is more than 3 months; 5. ECOG score 0-2 points (see Attachment 2); 6. Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up; 7. Those who voluntarily participate in the trial and sign the informed consent.

Exclusion criteria

1. Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels; 2. Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system; 3. Use chemotherapy or radiotherapy within 3 days before the blood collection period; 4. Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids); 5. Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period; 6. Those who have previously used any gene therapy products; 7. History of epilepsy or other diseases of the central nervous system; 8. New York Heart Association (NYHA) class III or above (see Annex 3); 9. creatinine\> 1.5 times the upper limit of normal or ALT / AST\> 3 times the upper limit of normal or bilirubin\> 2 times the normal upper limit; 10. active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections; 11. pregnant or lactating women; 12. suffer from other uncontrolled diseases that the researcher considers inappropriate; 13. Any condition that the investigator believes may increase the subject's risk or interfere with the test results.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

China

Contacts

Primary ContactXin-an Lu, Dr

luxinan@immunochina.com86-189-1157-6946

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026