Actively Recruiting
CD70 Targeted CAR-T Cells in CD70 Positive Relapsed/Refractory Lymphoma
Led by Chinese PLA General Hospital · Updated on 2023-07-17
30
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
U
UTC Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
CONDITIONS
Official Title
CD70 Targeted CAR-T Cells in CD70 Positive Relapsed/Refractory Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- ECOG performance status of 2 or less and estimated life expectancy over 3 months
- Histologically confirmed lymphoma including Hodgkin lymphoma, aggressive B-cell non-Hodgkin's lymphoma, and indolent lymphoma
- Relapse after at least two lines of systemic therapy or refractory disease as defined
- CD70 antigen expression of 10% or higher
- Successful leukapheresis and T cell preculture
- At least one measurable tumor focus by CT or MRI
- Adequate organ function including blood counts, liver, kidney, heart, and lung function
- Toxicity from prior therapy grade 1 or less or acceptable per investigator
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during treatment and for 1 year after
- Ability to understand and sign informed consent
You will not qualify if you...
- Use of corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive drugs within 14 days prior to enrollment
- Receipt of cytotoxic chemotherapy, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives prior to enrollment
- Pregnant, lactating, or breastfeeding women
- Active uncontrolled infections including viral, bacterial, or fungal
- Positive HIV/AIDS test or active hepatitis B or C infection
- History of allergy or intolerance to study drug components
- Prior organ transplant or allogeneic stem cell transplantation
- Major surgery or trauma within 28 days prior to enrollment or unresolved major side effects
- Known brain metastases or active central nervous system involvement
- Other cancer within 5 years except certain treated cancers
- Serious medical or psychiatric conditions limiting study compliance
- Vaccination within 30 days of enrollment
- Previous treatment targeting CD70
- Participation or withdrawal from other trials within 4 weeks
- Other reasons deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China
Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
Y
Yang Liu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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