A Clinical Study to Explore CT1195E in Patients With Relapsed/Refractory B-Cell Neoplasms

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

A Clinical Study to Explore the Safety, Efficacy and Cellular Metabolic Kinetics of CT1195E CAR-T Cells Injection in Patients with Relapsed/Refractory B-Cell Neoplasms

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

R/R B-NHL Inclusion Criteria:

Cohort A1: Patients who have previously received standard systemic therapy, including regimens containing anti-CD20 drugs (except CD20 negative) and anthracyclines;

Cohort A2: Prior standard systemic therapy, including an anti-CD20 agent (except CD20 negative) , anthracycline or bendamustine-containing regimen, and a BTK inhibitor;

Hematology: ① Platelet (PLT) ≥ 75 × 109/L (study participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 109/L), ② Hemoglobin (Hb) ≥ 80 g/L (study participants with bone marrow or peripheral blood involvement: Hb ≥ 60 g/L);

Disqualifiers

R/R B-NHL Exclusion Criteria:

Pregnant or lactating females;

Study participants with a history of neurological disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disorders or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;

Presence of HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR T cells chimeric antigenreceptor cells

    Drug

    CT1195E cells infusion

Treatment groups

30 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

To assess the severity and incidence of DLTs, treatment-related adverse events (TRAE), and adverse events of special interest (AESI) after CT1195E infusion

Time frame
12 months after CT1195E infusion
2

MTD or dose range

To explore the maximum tolerated dose (MTD) or dose range of CT1195E

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

Secondary outcomes

1

Overall Response Rate (ORR)

Time frame
Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion
2

Complete response rate (CRR)

Time frame
12 months after CT1195E infusion
3

Minimal Residual Disease Negative (MRD-) Proportion (R/R B-ALL)

Time frame
12 months after CT1195E infusion
4

Duration of response (DOR)

Time frame
12 months after CT1195E infusion

Other outcomes

Sponsors and contacts

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