Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
NCT ID: NCT05651100
Last Updated: 2022-12-14
Study Results
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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NOT_YET_RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2022-12-10
2025-12-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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arm 1
sequential CD19 and CD22 targeted CAR-T cells treat
CD19 and CD22 targeted CAR-T cells
CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (300 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given.（anti-CD19 CAR-T first, then anti-CD22 CAR-T).
Interventions
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CD19 and CD22 targeted CAR-T cells
CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (300 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given.（anti-CD19 CAR-T first, then anti-CD22 CAR-T).
Eligibility Criteria
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Inclusion Criteria
2. KPS\>60.
3. Life expectancy\>12 weeks.
4. Gender unlimited, age from 3 years to 70 years.
5. Evidence for cell membrane CD19 and/or CD22 expression;
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
Exclusion Criteria
2. Patients are allergic to cytokines.
3. Uncontrolled active infection.
4. Acute or chronic GVHD.
5. Treated with T cell inhibitor.
6. Patients who had used steroid hormones within one week.
7. Patients who had used Rituximab within two weeks.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
3 Years
70 Years
ALL
No
Sponsors
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Hebei Yanda Ludaopei Hospital
OTHER
Kecellitics Biotech Company Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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li xiangqun, doctor
Role: STUDY_CHAIR
Kecellitics Biotech Company Ltd
Locations
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Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Li xiangqun, Doctor
Role: primary
Other Identifiers
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Kece-4
Identifier Type: -
Identifier Source: org_study_id