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Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies

ConditionsMyeloid MalignanciesCAR-T
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

This is an open-label, single-arm, exploratory clinical trial utilizing a "3+3" dose escalation followed by dose expansion to evaluate the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), and preliminary efficacy of CD33/CD123/CLL-1 CAR-T cell therapy in patients with relapsed/refractory myeloid malignancies.

Part A: Dose Escalation Phase. Follows a "3+3" dose escalation design with four predefined dose cohorts: 0.2×10⁶, 0.5×10⁶, 1×10⁶, and 2×10⁶ CAR-positive cells/kg.Anticipated enrollment: 12-24 subjects.Primary objectives: Assess safety, tolerability, and determine MTD.Dose-limiting toxicity (DLT) observation period: 28 days post-infusion.

Part B: Dose Expansion Phase.Enrolls 21 additional subjects to receive CAR-T cell infusion at the recommended Phase 2 dose (RP2D) established in Part A.Primary objective: Further evaluate therapeutic efficacy.

Overall Study Objectives:Safety profile of CD33/CD123/CLL-1 CAR-T therapy.Efficacy endpoints (e.g., response rates, survival outcomes).Pharmacokinetic characterization of CAR-T cells (expansion/persistence).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent: Willing and able to provide written informed consent, with commitment to comply with scheduled visits, study treatment, laboratory tests, and other trial procedures.

Disqualifiers

Cardiac Dysfunction: Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) <50%.

Trial design

Design model

Single group

Treatments tested in this trial

  • CD33/CD123/CLL-1 CAR-T Cells

    Drug

    Part A: Dose Escalation Phase. Follows a "3+3" dose escalation design with four predefined dose cohorts: 0.2×10⁶, 0.5×10⁶, 1×10⁶, and 2×10⁶ CAR-positive cells/kg.Anticipated enrollment: 12-24 subjects.Primary objectives: Assess safety, tolerability, and determine MTD.Dose-limiting toxicity (DLT) observation period: 28 days post-infusion. Part B: Dose Expansion Phase.Enrolls 21 additional subjects to receive CAR-T cell infusion at the recommended Phase 2 dose (RP2D) established in Part A.Primary objective: Further evaluate therapeutic efficacy.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: CAR-T Cells infusion（ CD33/CD123/CLL-1 CAR-T）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of adverse events

Time frame
Day 28

Secondary outcomes

1

Objective response rate (ORR)

Time frame
At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
2

Complete response rate (CRR)

Time frame
At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
3

Duration of response (DOR)

Time frame
At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
4

Progression free survival (PFS)

Time frame
At 3, 6, 9, 12, 18, and 24 months post-treatment follow up

Other outcomes

1

Kinetics of CAR-T cells

Use flow cytometry or Q-PCR to monitor the kinetics of CAR-T cells.

Time frame
At 3, 6, 9, 12, 18, and 24 months post-treatment follow up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Hebei Taihe Chunyu Biotechnology Co., Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: