Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: B Cell Lymphoma

Treatments: Combination Product: CAR-T

Study type: Interventional

Funder types: Other

Identifiers

NCT03258047

lymphoma center Q002

Details and patient eligibility

About

It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.

Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years, male or female;
2. Karnofsky≥60%；
3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
5. Patients have had more than 2 combined chemotherapy regimens;
6. Creatinin <2.5mg/dL；ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL；
7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;
8. Patient that could understand and is willing to sign the written consent;
9. Fertile female patient should be willing to take contraceptive measures.
10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion criteria

1. Patients who need ≥15mg prednisone daily due to any cause;
2. Patients with autoimmune disease and need immunosuppressor treatment;
3. Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
4. FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%；
5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%；
6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
7. Patients that have previously received gene therapy of any kind;
8. Obvious clinical encephalopathy or novel neuron function damage;
9. Patients with active infection;
10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
11. Patients who had allergic history to agents of the similar structure as CAR-T;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

CAR-T treatment

Experimental group

Description:

In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated

Treatment:

Combination Product: CAR-T