Actively Recruiting
The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors
Led by Tianjin Medical University General Hospital · Updated on 2025-04-04
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University General Hospital
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating CAR-T cell therapy as a treatment for adults with relapsed or refractory malignant hematologic tumors, including various types of aggressive B-cell lymphoma, T-cell lymphoma, acute lymphoblastic leukemia, multiple myeloma, and myeloid tumors. This Phase I/II open-label study aims to investigate the safety, determine the maximum tolerated dose, and assess early effectiveness of CAR-T cell infusions in these conditions. The study uses a dose-escalation approach, starting with small groups of patients receiving increasing doses of CAR-T cells to find the safest maximum dose. After this, a larger group will receive the recommended dose to further evaluate how well the treatment works. The CAR-T cells used target specific tumor markers and are given as infusions. Different dose groups will receive between 1 million and 3 million CAR+ cells per kilogram of body weight, adjusted based on previous trial results. Participants will be monitored closely for adverse events within 28 days after treatment and followed for up to 24 months to assess response rates, duration of response, progression-free survival, and overall survival. The study involves regular visits with clinical evaluations, laboratory tests, and follow-up assessments to track safety and effectiveness. Participants will need to comply with study requirements, including visits, tests, and treatment procedures throughout the study duration.
CONDITIONS
Brief Title
The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent and agree to comply with study visits and procedures
- Diagnosed with relapsed or refractory malignant hematologic tumors
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival of more than 3 months from consent date
- Hemoglobin level of at least 60 g/L (transfusion allowed)
- Adequate liver, kidney, heart, and lung function as defined by study criteria
- Agree to use contraception if planning pregnancy before and for six months after study
- Specific diagnosis confirmation for lymphoma, leukemia, multiple myeloma, or myeloid tumor cohorts as detailed in the protocol
You will not qualify if you...
- Severe heart failure with left ventricular ejection fraction below 50%
- Severe lung disease affecting lung function
- Active other malignant tumors in progressive stages
- Severe infections that cannot be controlled
- Severe autoimmune diseases or congenital immunodeficiency
- Active hepatitis B or C infection above detection limits
- HIV infection, AIDS, or syphilis infection
- History of severe allergic reactions to biological products including antibiotics
- Recent acute graft-versus-host disease after allogeneic stem cell transplant
- Other serious physical or mental illnesses or abnormal lab tests increasing study risk or interfering with results
- Investigator judgment deeming participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Dose-escalation followed by dose-expansion phase lasting up to 2 years
Participants receive CAR-T cell infusion treatment for relapsed and refractory malignant hematologic tumors at doses determined by the study phase.
1 infusion visit plus multiple follow-up visits over 24 months
Duration - Up to 24 months post-treatment
Participants are monitored for safety and treatment efficacy with assessments up to 24 months after treatment.
Visits at 3, 6, 9, 12, 18, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
TianJin China. TianJin Medical University General
Tianjin, Tianjin Municipality, China, 300072
Actively Recruiting
Research Team
R
Rong Fu
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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