Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06037018
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2023-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
Sponsor:
CytoCares Inc
Organization:
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1, open-label, dose-escalation study to evaluate the safety, PK, PD and immunogenicity of CC312 following intravenous doses of CC312 in patients with relapsed and refractory (r/r) CD19 expressing B-cell non-Hodgkin lymphoma and B-cell lymphocytic leukemia.
Detailed Description:
This study is an accelerated dose titration design divided into 2 parts.
Part 1 of the study is an accelerated dose-escalation design involving 5 dose levels: 0.3, 0.6, 1.2, 2.4 and 4.8 mcg given intravenously (IV) with cohorts of one patient per dose level. Patients in this part will receive 1 priming dose (D-7) and 1 intermediate dose of CC312 (D-3) on the first week, followed by twice weekly dosing of escalated dose for three weeks beginning on the second week. The dose limiting toxicity (DLT) observation period will be 28 days. The optimal priming dose and intermediate dose level will be determined in this part.
Part 2-A will follow a standard 3 + 3 dose escalation design using five dose levels: 9.6, 16, 24, 34 and 45 μg to obtain data on the safety and tolerability of CC312. Patients in this part will receive priming dose and intermediate dose of CC312 established in Part 1 before given the treatment dose. MTD or RP2D will be determined in Part 2-A and tested in expanded population(Part 2-B).
Part 2-B is planned for cohorts of 6-10 patients with B-cell non-Hodgkin lymphoma or B-cell lymphocytic leukemia receiving priming/ treatment dose levels as defined in the Part 1 and Part 2-A study.
Part 1 of the study is an accelerated dose-escalation design involving 5 dose levels: 0.3, 0.6, 1.2, 2.4 and 4.8 mcg given intravenously (IV) with cohorts of one patient per dose level. Patients in this part will receive 1 priming dose (D-7) and 1 intermediate dose of CC312 (D-3) on the first week, followed by twice weekly dosing of escalated dose for three weeks beginning on the second week. The dose limiting toxicity (DLT) observation period will be 28 days. The optimal priming dose and intermediate dose level will be determined in this part.
Part 2-A will follow a standard 3 + 3 dose escalation design using five dose levels: 9.6, 16, 24, 34 and 45 μg to obtain data on the safety and tolerability of CC312. Patients in this part will receive priming dose and intermediate dose of CC312 established in Part 1 before given the treatment dose. MTD or RP2D will be determined in Part 2-A and tested in expanded population(Part 2-B).
Part 2-B is planned for cohorts of 6-10 patients with B-cell non-Hodgkin lymphoma or B-cell lymphocytic leukemia receiving priming/ treatment dose levels as defined in the Part 1 and Part 2-A study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: