PD1-CD19-CART in Patients With r/r B-cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2023-11-10

Brief Summary

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This is an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the treatment with PD1-CD19-CART.

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Detailed Description

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PD1-CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene integration and also PD1 knockout by one-step gene-editing. After completion of study treatment, subject participation for this study will be followed up to 15 years post T cell infusion.

Conditions

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B-cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Patients will receive one of the three doses of 2\*10\^6/kg, 4\*10\^6/kg,6\*10\^6/kg.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD1-CD19-CART

Patients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of PD1-CD19-CART will be infused on day 0.

Group Type EXPERIMENTAL

PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells

Intervention Type BIOLOGICAL

Gene editing autologous T cells with anti-CD19 ScFv expression and knockout of PD1

Interventions

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PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells

Gene editing autologous T cells with anti-CD19 ScFv expression and knockout of PD1

Intervention Type BIOLOGICAL

Other Intervention Names

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PD1-CD19-CART

Eligibility Criteria

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Inclusion Criteria

1. Have the capacity to give informed consent;
2. ALL patients with the age between 18 and 70 years old;
3. Expected survival \>3 moths;
4. With no severe heart and lung disease;
5. Previously confirmed diagnosis as CD19+ NHL within 6 months;
6. Hematological index as following, white blood cell (WBC)≥1.5×10\^9/L，absolute neutrophil count (ANC) ≥0.8×10\^9/L, Platelet count≥50×109/L, Hemoglobin (Hgb) ≥ 90mg/L, lymphocyte count≥ 0.4×10\^9/L；
7. Blood biochemical index as no more than 1.5\* ULN, including total bilirubin (TBIL), transglutaminase (AST), alanine aminotransferase (AST), Creatinine (SCr), Urea in patients with no tumor metastasis in liver and kidney; Blood biochemical index no more than 5\* ULN in patients with tumor metastasis in liver and kidney;
8. With a stable cardiac function, the left ventricular ejection fraction (LVEF) ≥ 55%;
9. Virological tests were negative for EBV, CMV, HIV, TP and HCV; a negative HBV DNA test is acceptable if HBsAg is positive;
10. ECOG \<2;
11. Relapsed or refractory (r/r) NHL including, Diffuse large B cell lymphoma(DLBCL, NOS), stage Ⅲ-Ⅳ;Primary mediastinal large B-cell lymphoma (PMBL), stage Ⅲ-Ⅳ; High grade B-cell lymphoma (HGBL), stage Ⅲ-Ⅳ; Mantle cell lymphoma (MCL), stage Ⅲ-Ⅳ; follicular lymphoma (FL), stage Ⅲ-Ⅳ and with aggression. r/r NHL defined as following, demonstrate disease that persists or relapse after achieving complete response (CR) after \> 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT), or not achieving CR after auto-HSCT.

Exclusion Criteria

1. Pregnant or lactating women;
2. With a pregnancy plan in the next 2 years;
3. Prior treatment of anti-GVHD therapy;
4. Acceptance of allogeneic stem cell transplant (ASCT);
5. Isolated extramedullary relapse of ALL;
6. Severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases;
7. Partial prothrombin time or activated partial thromboplastin time or international standardized ratio \> 1.5\*ULN without anticoagulant treatment;
8. History of other type of maligant tumors;
9. Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No