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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Fully human CD5 chimeric antigen receptor T cell injection
DrugCA5 CART cells were reinfused
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Fully human CD5 chimeric antigen receptor T cell injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Main objectives
To evaluate the safety of CD5 chimeric antigen receptor T cell injection (CD5CART) in the treatment of subjects with relapsed and refractory CD5 hematological tumors, and to explore the maximum tolerated dose (MTD).
Time frame
one monthSecondary outcomes
1
ORR
The proportion of subjects evaluated as complete response (CR) and partial response (PR) according to Lugano 2014 efficacy evaluation criteria after CD5CART infusion
Time frame
weeks 4 and 12 after CAR-T infusion2
Time to Response (TTR)
Time from CAR-T infusion to first documentation of response evaluated by an IRC or investigators
Time frame
in 2 years post CAR-T infusion3
Best overall response rate (BOR)
The proportion of subjects who received CD5CART infusion and had the best efficacy evaluation as PR or CR
Time frame
within 3 months post CAR-T infusion4
Duration of response (DOR)
The time from the first assessment of CR/PR to the first assessment of PD or death from any cause in the subject after receiving CD5CART infusion
Time frame
Minimum of 2 years post CAR-T infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Beijing Gaobo Boren Hospital
Collaborator
Source ClinicalTrials.gov