Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Anti-FLT3 CAR-T cells — DRUG
  Anti-FLT3 CAR-T cells is administered by intravenous infusion following standard lymphodepleting chemotherapy consisting of fludarabine and cyclophosphamide.

Study Details

This is a phase 1 dose escalation study to determine the safety of anti-FLT3 CAR-T in subjects with R/R AML. The primary objective is to assess safety. Up to 18 evaluable adult and 18 evaluable pediatric subjects will be enrolled. Evaluable subjects are defined as those who have received an infusion of HG-CT-1. Primary clinical objectives: i. Determine the safety of HG-CT-1 based on the proportion of subjects infused with HG-CT-1 who experience a dose limiting toxicity (DLT). Secondary clinical objectives: i. Estimate the efficacy of HG-CT-1 according to standard clinical response criteria for AML. ii. Estimate overall survival of evaluable subjects. iii. Estimate progression-free survival of evaluable subjects. iv. Estimate duration of response in evaluable subjects who achieve a response. Secondary scientific objectives: i. Describe the persistence and trafficking of HG-CT-1. ii. Describe HG-CT-1 bioactivity and its predictors.

Key Dates

Start date

Jan 23, 2025

Status verified

Aug 2025

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

18 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose level 1: 7x10^7 Transduced CAR+ HG-CT-1
• Experimental: Dose level 2: 1.4x10^8 Transduced CAR+ HG-CT-1
• Experimental: Dose level 3: 3.5x10^8 Transduced CAR+ HG-CT-1
• Experimental: Dose level -1: 3.5 x 10^7 Transduced CAR+ HG-CT-1

Primary Outcome Measure

Determine the safety of HG-CT-1 cells based on the proportion of subjects infused with HG-CT-1 who experience a DLT. [ Time Frame: From the time of HG-CT-1 infusion until Day 28 ]

Locations (1)

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