Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma
Conditions
Brief summary
A study of CT-RD06 cell injection in patients with relapsed or refractory CD19+ B-cell hematological malignancy.
Detailed description
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-cell hematological malignancy: B-ALL and B-NHL, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 2 groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.
Interventions
BIOLOGICALCT-RD06
CT-RD06 cell injection by intravenous infusion
Sponsors
Nanjing Bioheng Biotech Co., Ltd.
He Huang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria only for B-ALL: 1. Male or female aged 3-70 years; 2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1); 3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is ≤ 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; 4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is﹥5% (by morphology), and/or﹥1% (by flow cytometry); 5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments; * Inclusion criteria only for B-NHL: 1. Male or female aged 18-70 years; 2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016); 3. Relapsed or refractory B-NHL (meeting one of the following conditions): 1. No response or relapse after second-line or above chemotherapy regimens; 2. Primary drug resistance; 3. Relapse after auto-HSCT; 4. At least one assessable tumor lesion per Lugano 2014 criteria; * Common inclusion criteria for B-ALL and B-NHL: 1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; 3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; 4. Estimated survival time ≥ 3 months; 5. ECOG performance status 0 to 2; 6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion criteria
* Inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | Baseline up to 28 days after CT-RD06 infusion | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 2 years after CT-RD06 infusion | Incidence of treatment-emergent adverse events \[Safety and Tolerability\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR) | At Month 1, 3, 6, 12, 18 and 24 | Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24 |
| B-ALL, Overall survival (OS) | Up to 2 years after CT-RD06 infusion | From the first infusion of CT-RD06 to death or the last visit |
| B-ALL, Event-free survival (EFS) | Up to 2 years after CT-RD06 infusion | From the first infusion of CT-RD06 to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit |
| B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR) | At Week 4, 12, and Month 6, 12, 18, 24 | Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria |
| B-NHL, disease control rate (DCR) | At Week 12 and Month 6, 12, 18, 24 | Assessment of DCR (DCR=CR+PR+SD) per Lugano 2014 criteria |
Countries
China
Outcome results
None listed