Treatment of Hematological Malignancy With Novel CAR-T Cells.

T

Timmune Biotech

Status and phase

Unknown
Early Phase 1

Conditions

Multiple Myeloma
B-cell Non Hodgkin Lymphoma
B-cell Acute Lymphoblastic Leukemia

Treatments

Biological: Novel CAR-T

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04191941
2019-24.1

Details and patient eligibility

About

This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.

Full description

The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment,as well as stimulating innate T/NK cell activation and expansion.

Enrollment

9 estimated patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
  • All subjects must be able to comply with all the scheduled procedures in the study;
  • Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
  • Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
  • At least one clear indicator for hematological malignancy monitoring;
  • Aged <70 years;
  • Expected survival ≥12 weeks;
  • Eastern cooperative oncology group (ECOG) performance status of≤3;
  • Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;

All other treatment induced adverse events must have been resolved to

≤grade 1;

Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion criteria

  • Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);
  • Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
  • Lactating women or women of childbearing age who plan to conceive during the investigational time period;
  • Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
  • Known history of infection with HIV;
  • Subjects need systematic usage of corticosteroid;
  • Subjects need systematic usage of immunosuppressive drug;
  • Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
  • Other reasons the investigator consider the patient may not be suitable for the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Novel CAR-T
Experimental group
Description:
Novel CAR-T cells will be administered intravenously
Treatment:
Biological: Novel CAR-T

Trial contacts and locations

0

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Central trial contact

Ming Zhou; Bin Gao

Data sourced from clinicaltrials.gov

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