Study of MT027 in Patients with Recurrent or Progressive High-grade Glioma

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuzhou Maximum Bio-tech Co., Ltd.

About this trial

The clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ cells per dose. The injection will be administered once every three weeks, adopting a "3 + 3" dose escalation design. The dosing interval is based on the pharmacokinetic (PK), safety and preliminary efficacy data of MT027 investigator-initiated trial (IIT) previously conducted at Dushu Lake Hospital of Soochow University. Accordingly, it is recommended to maintain the dosing interval of once every three weeks, with a window period of ±7 days. According to past experience, the dosing cycle should be at least 6 cycles, with each cycle lasting 21 days. If patients still benefit after more than 6 cycles, they can continue to receive the medication until no further benefit is achieved. The number of treatment sessions is approximately 6 to 9 times. However, the specific number of treatment sessions will generally be determined by the investigator based on the patient's disease condition.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this study and sign the informed consent form.

Be aged between 18 and 70 years old (including the critical values), with no gender limitation.

Subjects with high-grade glioma diagnosed pathologically (referring to grade 3 or 4 in the "WHO (2021) Classification of Tumors of the Central Nervous System"), who have progressive disease during standard treatment or have recurrence after standard treatment.

Enhanced MRI shows space-occupying lesions in the brain, and there is at least one measurable lesion (according to the iRANO 2010 version criteria).

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • MT027 cells suspension

    Drug

    MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: MT027Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame
through study completion, an average of 1 year
2

Dose Limiting Toxicity (DLT)

Time frame
28 days
3

Immune effector cell-associated neurotoxicity syndrome (ICANs)

Time frame
through study completion, an average of 1 year
4

GvHD

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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

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