Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorAnhui Provincial Hospital
About this trial
This is an open label, single-site, dose-escalation study in up to 18 participants with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient or his/her guardian is fully informed and agrees to participate in this clinical study and signs the informed consent form;
At the time of signing the informed consent form, be over 3 years of age, regardless of gender;
B diffuse large B-cell lymphoma (DLBCL), germinal center, or activated B-cell type; Primary cutaneous DLBCL; Primary mediastinal (thymic) large B-cell lymphoma; ALK anaplastic large B-cell lymphoma; High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement (i.e., "double or triple hit"); High-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma caused by indolent lymphoma; follicular lymphoma; mantle cell lymphoma; Patients with large cell transformation (Richter's Transformation) with CLL who have not achieved remission or have progressed after achieving remission after at least 1 prior line of therapy.
Patients diagnosed with acute B-cell leukemia: Patients who have achieved relapse after achieving remission after prior chemotherapy; or patients who have failed to achieve remission (<5% bone marrow blasts or persistent extramedullary or central nervous system disease) after 2 prior cycles of induction chemotherapy, or who still maintain MRD.
Disqualifiers
Episodes of central nervous system disease or presence of pathological changes within 6 months prior to screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental disorder;
patients with B-ALL with confirmed diagnosis of isolated extramedullary recurrence;
presence of malignancies other than acute B-cell leukemia/B-cell lymphoma;
Received the following anti-tumor therapies before cell collection: chemotherapy, targeted therapy, and other drug therapy within 14 days or at least 5 half-lives; Radiotherapy within 14 days;
Trial design
Design model
Sequential
Treatments tested in this trial
Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis
DrugA single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-5.0 x10\^5 CART cells/kg）.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Experimental: Anti-BCMA and CD19 CARTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1. Adverse events
Total number, incidence and severity of adverse events (AEs) in patients of ECAR01 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
Time frame
up to 2 yearsSecondary outcomes
1
2.The persistence, accumulation, and migration of CART cells
Assessing the trafficking of CART cells in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline.
Time frame
up to 2 years2
Progression free survival (PFS)
Progression Free Survival (PFS) defined as the time from treatment to first documentation of objective leukemic progression (date of leukaemia assessment documenting progressive disease) or to death due to any cause. Progression is assessed by BM biopsy or CSF analysis according to NCCN criteria. It is assessed at Day 90 or earlier if clinically indicated.
Time frame
up to 2 years3
Overall survival (OS)
Overall Survival (OS) defined as the time from treatment to the date of death due to any cause.
Time frame
up to 2 years4
Objective Response Rate (ORR)
Overall response rate (ORR) is defined as proportion of participants who achieve overall response (CR/CRi).
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov