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

B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03258047
• Other study ID #: lymphoma center Q002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 15, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: February 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 30, 2019
• Est. primary completion date: January 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Combination Product:
• CAR-T
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.

Locations

Country	Name	City	State
China	The first affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate	complete remission rate after treated by CAR-T therapy	every 3 months until 20 months after the last patient's enrollment
Secondary	progression free survival	from date of inclusion to date of progression, relapse, or death from any cause	from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment
Secondary	overall survival	from the date of inclusion to date of death, irrespective of cause	20 months after the last patient's enrollment
Secondary	adverse events	any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure	from the date of the start of treatment to 20 months after last patient's enrollment
Secondary	duration of the modified T cells by CAR-T in the patients	time from re-transfusion to date when the modified T cells become non-detectable.	from the date of re-transfusison to 20 months after last patient's enrollment