Clinical trial · Interventional
CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CLL1-/CD33 Targeted LCAR-AMDR Cells Product in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Both the sponsors and collaborator are considering terminating the study
Summary
Brief summary (as posted)
This is a prospective, single-arm, open-label, single dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-AMDR cells in subjects with relapsed/refractory Acute Myeloid Leukemia who received adequate standard therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCAR-AMDR Cells Product | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LCAR-AMDR Cells Product
- description
- Each subject will be treated with LCAR-AMDR Cells
- interventionNames
- Biological: LCAR-AMDR Cells Product
Primary outcomes (3)
- measure
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
- timeFrame
- Time Frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)
- description
- An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment
- measure
- Recommended Phase 2 dose (RP2D) finding
- timeFrame
- 30 days after LCAR-AMDR infusion (Day 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF)(For minors, the guardian shall also provide written informed consent ); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease; 2. Age 14-60 years; 3. ECOG score: ≤2; 4. Relapsed/refractory AML must meet one of the following conditions: 1. Twice or more relapse; 2. Newly diagnosed AML patients who failed after 2 cycles of standard chemotherapy; 3. Relapse within 12 months after CR, or relapse after 12 months with CR but failed to respond to conventional chemotherapy; 4. Persistent extramedullary leukemia. 5. Meet the requirements of allogeneic HSCT 6. Expected survival ≥ 3 months; Exclusion Criteria: 1. Subject with APL/AML-M3:t(15;17)(q22;q12) 2. Received any of the following treatments: * Previous allo-HSCT(Subjects who received allo-HSCT for more than 6 months, have stopped immunosuppressive drugs and have no active GvHD are not included in the exclusion criteria) * Previous gene therapy * Previous anti CD33/CLL1 therapy * Previous any target CAR-T cells therapy 3. Prior antitumor therapy with insufficient washout period; 4. CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission; 5. HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 6. Pregnant or breast-feeding women;
References
Publications (0)
Data not yet available