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

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Beijing Immunochina Medical Science & Technology

Status and phase

Unknown
Phase 1

Conditions

Non Hodgkin Lymphoma

Treatments

Biological: IM19
Drug: Cyclophosphamide
Drug: Fludarabine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03528421
YMCART201705

Details and patient eligibility

About

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.

Full description

Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

IM19 CAR-T cells
Experimental group
Description:
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
Treatment:
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: IM19

Trial contacts and locations

1

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Central trial contact

Xin-an Lu, Dr

Data sourced from clinicaltrials.gov

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