CD5 CART for the Treatment of Relapsed and Refractory CD5 Hematological Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-70
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
This is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological malignancies. At the same time, the effectiveness and pharmacokinetic characteristics of CD5CART treatment of relapsed and refractory CD5 hematological tumors in subjects were explored
Eligibility criteria
Qualifiers
Chronic lymphocytic leukemia/small lymphocytic lymphoma: Received any BTK inhibitor for at least 6 months and was ineffective (disease is in SD or PD state).
Mantle cell lymphoma: Relapsed/refractory disease with at least one treatment regimen, prior treatment must include chemotherapy with anthracyclines or bendamustine, anti-CD20 monoclonal antibody, and therapy with any BTK inhibitor.
Diffuse large B-cell lymphoma: Patients with diffuse large B-cell lymphoma who have refractory or relapsed after at least second-line therapy (one standard chemotherapy regimen and one salvage chemotherapy). At the same time, one of the following conditions is met: a. Unable to receive autologous hematopoietic stem cell transplantation; b. Refusal to receive autologous hematopoietic stem cell transplantation; c. Relapse after autologous hematopoietic stem cell transplantation.
Peripheral T-cell lymphoma (non-specific type)
Disqualifiers
Those who have a history of allergy to any component of cell products.
Grade II-IV. acute GVHD determined by Glucksberg criteria or grade B-D severity determined by IBMTR index; Patients with acute or chronic GVHD who required systemic treatment within four weeks prior to enrollment.
Subjects who have been injected with live vaccines within 4 weeks before enrollment.
Central nervous system diseases that are not related to lymphoma central invasion (such as brain aneurysm, epilepsy, stroke, Alzheimer's, psychosis, etc.). Lymphoma central invasion or gastrointestinal invasion is not used as an exclusion criterion, but enrollment is at the discretion of the investigator.
Trial design
Treatments tested in this trial
- Fully human CD5 chimeric antigen receptor T cell injection
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Beijing Gaobo Boren Hospital
Collaborator
Source ClinicalTrials.gov