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A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Completed
Phase 1

Conditions

B-cell Non-Hodgkin Lymphoma

Treatments

Biological: CD19-directed CAR-T cells

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03483688
CBMG-C2017007

Details and patient eligibility

About

This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).

Full description

The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up

Enrollment

6 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Volunteered to participate in this study and signed informed consent.

  • Age 18-70 years old, male or female.

  • Relapse or refractory B cell non-Hodgkin's lymphoma ,Histologically diagnosed as DLBCL,follicular lymphoma and Mantle cell lymphoma according to the NCCN. nonHodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)

    1. DLBCL and Follicular Lymphoma (stage Ⅲ-Ⅳ, grade Ⅲb).

      1. Progressive disease after the last standard chemotherapy regimens.
      2. Stable disease after the last standard chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later-line therapy).
      3. Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT).
    2. Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)

      1. Relapse or progressive disease within 1 year after the last standard chemotherapy regimens(At least 2 combination chemotherapy regimens).
      2. Stable disease after the last standard chemotherapy regimens(at least 2 cycles of combination chemotherapy regimens).
    3. Mantle cell lymphoma

      1. Relapse after 1st CR or persistent disease, and not eligible or appropriate for SCT.
      2. Relapse or progressive disease within 1 year after the last chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later- line therapy).
      3. Relapse or progressive disease within 12 months after autologous SCT.
  • All subjects must have received anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline-containing chemotherapy regimens according to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1).

  • At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5cm).

  • Expected survival ≥ 12 weeks.

  • ECOG score 0-1.

  • Left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography).

  • No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.

  • At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy) prior to leukapheresis.

  • No contraindications of leukapheresis.

  • Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial.

Exclusion criteria

  • History of allergy to cellular products.

  • Laboratory tests: absolute neutrophil count < 1.0 × 10^9 /L, platelet count < 50×10^9 /L, serum albumin < 30 g/L,serum bilirubin > 1.5 ULN, serum creatinine > ULN, ALT/AST > 3 ULN.

  • History of CAR T cell therapy or any other genetically modified T cell therapy.

  • Relapse after allogeneic hematopoietic stem cell transplantation.

  • Active infections that require treatment (uncomplicated urinary tract infections and bacterial pharyngitis are allowed), prophylactic antibiotic, antiviral and antifungal treatment are permitted.

  • Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired or congenital immune deficiency diseases, including but not limited to HIV infection.

  • Class III or IV heart failure according to the NYHA Heart Failure Classifications.

  • QT interval prolongation ≥ 450 ms.

  • History of epilepsy or other central nervous system disorders.

  • Evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging.

  • History of other primary cancers, with the following exceptions.

    1. Excisional non-melanoma (e.g. cutaneous basal cell carcinoma).
    2. Cured in situ carcinoma (e.g. cervical cancer, bladder cancer, breast cancer).
  • Autoimmune diseases that require treatment, immune deficiency diseases or other diseases that require immunosuppressive therapy.

  • Used of systemic steroids within two weeks (using inhaled steroids is an exception).

  • Women who are pregnant or lactating, or who have breeding intent in 6 months.

  • Participated in any other clinical trial within three months.

  • Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

CD19-directed CAR-T cells
Experimental group
Description:
Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene
Treatment:
Biological: CD19-directed CAR-T cells

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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