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Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML

ConditionsAMLRefractory/Relapse Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

About this trial

A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years (inclusive), male or female.

Relapsed or refractory acute myeloid leukemia (R/R AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.

Bone marrow blasts ≥5% by morphology.

Estimated life expectancy >12 weeks.

Disqualifiers

Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;

Participants with a history of epilepsy or other central nervous system disease;

Participants who have previously received autologous or allogeneic CAR-T therapy;

Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR-T cells chimeric antigen receptor T cells

    Drug

    Conditioning regimen: Days -9 to -3: Venetoclax administered with a target dose of 200 mg/day. Days -5 to -4: Cytarabine administered at 500 mg/m²/day. Days -5 to -3: Cyclophosphamide at 300 mg/m²/day plus Fludarabine at 30 mg/m²/day. Day 0: Infusion of CT0890B CAR-T cells at one of four dose levels using an i3+3 Dose-Escalation Design: 1.5 × 10⁸ total cells, 3.0 × 10⁸ total cells, 4.5 × 10⁸ total cells, 6.0 × 10⁸ total cells

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: CAR-T cells chimeric antigen receptor T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AE) after CT0890B infusion

An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

Time frame
12 months after CT890B infusion
2

Dose-limiting toxicity (DLT)

The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0890B that meet the criteria for DLT events after the first infusion

Time frame
Up to 28 days after CAR-T cells infusion
3

MTD and/or dose range

Evaluate Dose limited toxicity and recommended dosage range after CT0890B infusion

Time frame
Up to 28 days after CAR-T cells infusion

Secondary outcomes

1

Composite response (CRc)

The composite response rate (CRc) included complete response (CR), complete response with partial hematologic recovery (CRh), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS). Responses were assessed in accordance with the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet criteria for acute myeloid leukemia (AML).

Time frame
12 months after CT0890B infusion
2

Partial response (PR)

Partial response (PR) was defined and assessed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet response criteria for AML.

Time frame
12 months after CT0890B infusion
3

Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy

This secondary endpoint was defined as the proportion of patients who proceeded to stem cell transplantation after CAR-T therapy during the study period.

Time frame
12 months after CT0890B infusion
4

Duration of response (DOR)

Patients achieving CR, CRi, CRh, or MLFS were included in the duration of response (DOR) analysis set. DOR was defined as the time from the date of first documented response to the date of disease relapse or death from any cause, whichever occurred first.

Time frame
12 months after CT0890B infusion

Other outcomes

Sponsors and contacts

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

Peking University People's Hospital

Lead sponsor

CARsgen Therapeutics Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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