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CLL1 and CD38 Dual-Target CAR-T Cell

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 3, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

CLL1 and CD38 Dual-Target CAR-T Cell · 1 trial · 1 indication

Phase 1 1
NCT06880354A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid LeukemiaAcute Myeloid Leukemia
RECRUITING37 Analytics
PHASE1RECRUITING
A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose-Limiting Toxicity (DLT) Rate
28 days

Proportion of subjects with DLT within 28 days after infusion of CLL1/CD38 dual-target CAR-T cell injection.

Adverse Events (AEs)
96 weeks

Proportion of subjects experiencing AE within 96 weeks after infusion of CLL1/CD38 dual-target CAR-T cell injection.

Secondary Endpoints

Complete Remission Rate (CRc)
96 weeks
Overall Response Rate (ORR)
96 weeks
MRD negative rate and MRD negative duration
96 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intervention(CLL1 and CD38 Dual-Target CAR-T Cell Injection)EXPERIMENTALThis study is a single-center open-label clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The enrolled subjects were patients with relapsed and refractory acute myeloid leukemia (r/r AML) .

Interventions

NameTypeDescription
CLL1 and CD38 Dual-Target CAR-T Cell InjectionDRUGThis product is a lentiviral gene-modified autologous chimeric antigen receptor T-cell product that targets both CLL1 and CD38.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. At the time of signing the informed consent, 18-70 years old (including the critical value); 2. Diagnosed with acute myeloid leukemia (except for APL) based on the World Health Organization (WHO) 2022 criteria and meeting the diagnostic criteria for relapsed/refractory AML (r...

Countries:China
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