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

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Collaborator: Beijing Cancer Hospital
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

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.