A Clinical Study of Allogenic CD19-CAR-T in the Treatment of R/R B-Cell Hematologic Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYANRU WANG
About this trial
This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed/refractory B-cell hematologic malignancies. 12 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 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The secondary objective is to evaluate the efficacy of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The exploratory objective is to evaluate expansion, persistence and ability of 19UCART to deplete CD19 positive cells in patients with relapsed/refractory B-cell hematologic malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation in this trial with signed informed consent.
Diagnosis of B-cell hematologic malignancy according to the 2017 WHO classification, including B-acute 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), etc.
Refractory or relapsed B-cell malignancy defined as failure to achieve complete remission after standard therapy, or relapse after achieving remission with first-line or salvage therapy.
Persistence of minimal residual disease (MRD) positivity despite hematologic remission in B-cell acute lymphoblastic leukemia (ALL).
Disqualifiers
Known hypersensitivity, allergic reaction, intolerance, or contraindication to 19UCART or any study-drug component (including fludarabine, cyclophosphamide, or tocilizumab), or history of severe anaphylaxis.
Post-allo-HSCT relapse with active graft-versus-host disease requiring systemic corticosteroids or other immunosuppressants.
Uncontrolled active infection of any etiology.
Active hepatitis B, hepatitis C, or tuberculosis.
Trial design
Design model
Single group
Treatments tested in this trial
19UCART injection
Biological/Vaccine19UCART injection is a CD19-targeted allogenic CAR-T. A single infusion of CAR-T cells will be administered intravenously.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: relapsed/refractory B-cell hematologic malignanciesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Toxicity and adverse-event grading after 19UCART treatment
all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0
Time frame
up to 12 months after infusion2
CRS grading after 19UCART treatment
CRS will be graded using the Lee DW et al. CRS grading scale
Time frame
up to 12 months after infusionSecondary outcomes
1
Overall response rate (ORR = CR + PR) of patients receive 19UCART treatment
according to the Lugano criteria and CSCO guidelines
Time frame
1, 3, 6, and 12 months after infusion2
Disease control rate (DCR = CR + PR + SD) of patients receive 19UCART treatment
according to the Lugano criteria and CSCO guidelines
Time frame
1, 3, 6, and 12 months after infusion3
PET-CT Response Criteria according to Lugano metabolic response categories
Tumor measurements and evaluations must be performed with the same technique used at baseline. CMR (5-PS 1-3 in all baseline sites); PMR (5-PS 4-5 but uptake ↓ vs base or ΔSUVmax ↓ ≥ 25 %); NMR (5-PS 4-5 with no significant Δ); PMD (5-PS 4-5 and uptake ↑ \> 50 % or new lesion). Deauville 5-Point Scale (5-PS): Scores 1-3 = metabolic CR; 4-5 = residual disease.
Time frame
1, 3, 6, and 12 months after infusion4
CAR copies and cell count of CAR-T in blood after 19UCART treatment
Time frame
Day 0, 1, 3, 5, 7, 9, 11, 14, 21, 28, and month 2, 3, 6, 9, 12 after 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
Allorunning Therapeutics
Collaborator
Source ClinicalTrials.gov
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