A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYANRU WANG
About this trial
A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness to participate in the trial and provision of signed informed consent.
Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic leukemia (B-ALL), and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle cell lymphoma (MCL), multiple myeloma (MM), etc.
Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line or salvage therapy.
Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
Disqualifiers
Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe allergic reactions.
Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
Severe active infection.
Acquired or congenital immunodeficiency.
Trial design
Design model
Single group
Treatments tested in this trial
RN1101 injection
DrugRN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously.
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: RN1101 treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events after RN1101 infusion
Time frame
up to 24 weeks after RN1101 infusionSecondary outcomes
1
Percentage of MRD negative patients after RN1101 treatment
Time frame
12 weeks, 24 weeks after RN1101 infusion2
ORR (PR, VGPR, CR and sCR) of patients receive RN1101 treatment
Time frame
12 weeks, 24 weeks after RN1101 infusion3
Progression free survival after RN1101 treatment
Time frame
12 weeks, 24 weeks after RN1101 infusion4
CAR copies and cell count of CAR-T in blood and bone marrow (if available) after RN1101 treatment
Time frame
12 weeks, 24 weeks after RN1101 infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
YANRU WANG
Lead sponsor
Affiliated Hospital of Jiangsu University
Sponsor institution
Rui Therapeutics Co., Ltd
Collaborator
Allorunning Therapeutics
Collaborator
Source ClinicalTrials.gov