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CLL1-CD33cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CLL1 and CD33 CARs

CLL1-CD33 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CLL1 and CD33 CARs.

CLL1-CD33 cCAR T cells

Kevin Pinz

Fang Liu, MD, PhD

Hongyu Zhang, MD, PhD

Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CLL1-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.

AML bears heterogeneous cells that can consequently offset killing by single-CAR-based therapy, which results in disease relapse. Leukemic stem cells (LSCs) associated with CLL1 expression comprise a rare population that also plays an important role in disease progression and relapse for myeloid malignancies. CD33 is widely expressed in AML, high risk myelodysplastic syndromes (MDS) and myeloproliferative neoplasms. Targeting both CD33 and CLL1 surface antigens together may offer two distinct benefits. First, targeting both bulk disease and leukemic stem cells together allows for a more comprehensive ablation of the disease. Second, dual targeting of myeloid malignancies by both CD33 and CLL1 directed therapy overcomes the pitfalls of single-antigen therapy by preventing relapse due to antigen loss. While loss of a single antigen under antigen-specific selection pressure is possible, loss of two antigens simultaneously is much less likely.

CLL1-CD33 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CLL1 and CD33. cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape and leukemic stem cells.

CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies

Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate The Safety and Tolerability of CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies.

Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies

The General Hospital of Western Theater Command

iCAR Bio Therapeutics Ltd.

Peking University Shenzhen Hospital

iCell Gene Therapeutics

Split intravenous infusion of anti-CLL1 CAR T cells \[dose escalating infusion of (5-20)x10\^6 anti-CLL1 CAR T cells/kg\].

anti-CLL1 CART

Xiaowen Tang, Ph.D

Lei Yu, Ph.D

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.

The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.

Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)

Pilot Study of the Safety and Efficacy of Anti-CLL1 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CLL1 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Adverse events are evaluated with CTCAE V5.0

ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

The date of enrollment to the date of death from any cause

Time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause

Time from the date of achievement of a remission to the date of relapse

The First Affiliated Hospital of Soochow University

Dose escalation: Three dose levels were designed, and if the maximum tolerated dose (MTD) was not found at the highest level, no further dose escalation was to be performed. Approximately 12-18 subjects were planned to be enrolled in the dose-escalation phase to evaluate the safety and tolerability of BG1805 injection and to determine the MTD and/or the recommended phase II dose (RP2D).

Dose Expansion: During or after the dose escalation process, if a certain dose group is determined to have preliminary anti-tumor effects and controllable safety, it can be extended at this dose level to further evaluate the tolerance and safety of BG1805 injection, and to preliminarily evaluate its effectiveness.

A single infusion of BG1805 Injection administered intravenously.

BG1805

Min Luo, Doctorate

Rui Huang, MD

Yu Zhang, MD

He Huang, MD

This is a single-arm, single-dose dose-escalation and dose-expansion study.

Patients with relapsed/refractory acute myeloid leukemia (r/r AML) were enrolled in the trial, which was divided into two parts: dose-escalation phase and dose-expansion phase.

Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

A Single-arm, Dose-escalation and Dose-expansion Phase I Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

After the infusion of BG1805, subjects still experienced adverse events, meeting the DLT definition, related to or possibly related to BG1805 infusion after optimal supportive treatment.

Defined as the proportion of subjects achieving complete response(CR), complete remission with incomplete blood cell recovery (CRi), morphologic leukemia-free state (MLFS), or partial response(PR).

Calculate the change of cytokine concentration in peripheral blood after After BG1805 infusion. Cytokines include IL-2、IL-6 and so on.

Guangzhou Bio-gene Technology Co., Ltd

Child patients with relapsed/refractory acute myeloid leukemia (r/r AML) were enrolled in the trial, which was divided into two parts: dose-escalation phase and dose-expansion phase.

BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children

A Single-arm, Dose-escalation and Dose-expansion Phase I Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies	NCT03795779	Hematologic Mal... Acute Myeloid L... Myelodysplastic... Myeloproliferat... Chronic Myeloid...	CLL1-CD33 cCAR ...	-	iCell Gene Therapeutics
Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)	NCT04884984	Acute Myeloid L...	anti-CLL1 CART	6 Years - 65 Years	The First Affiliated Hospital of Soochow University
Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia	NCT06118788	Leukemia, Myelo...	BG1805	18 Years - 70 Years	Guangzhou Bio-gene Technology Co., Ltd
BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children	NCT06347458	Leukemia Acute Myeloid L...	BG1805	3 Years - 18 Years	Guangzhou Bio-gene Technology Co., Ltd

Spots Global Cancer Trial Database for cll1

Every month we try and update this database with for cll1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cll1

Every month we try and update this database with for cll1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cll1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.