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OncoMatch/Clinical Trials/NCT06407947

Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma

Is NCT06407947 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Chimeric antigen receptor modified T cells Infusion for multiple myeloma.

Early Phase 1RecruitingShanghai Changzheng HospitalNCT06407947Data as of May 2026

Treatment: Chimeric antigen receptor modified T cells InfusionThis trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Biomarker criteria

Required: TP53 deletion (17p)

Meet any one or more of the cytogenetic criteria: del (17p)

Required: IGH t(4;14)

Meet any one or more of the cytogenetic criteria: t (4; 14)

Required: IGH t(14;16)

Meet any one or more of the cytogenetic criteria: t (14; 16)

Required: IGH t(14;20)

Meet any one or more of the cytogenetic criteria: t (14; 20)

Required: CKS1B 1q21 amplification ≥ 4 copies

Meet any one or more of the cytogenetic criteria: 1q21 amplification ≥ 4 copies

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 2 prior lines

Cannot have received: cytotoxic chemotherapy

Exception: up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction

Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy (patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy), epigenetic therapy, etc.

Cannot have received: proteasome inhibitor

Exception: up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction

Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy (patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy), epigenetic therapy, etc.

Cannot have received: immunomodulator

Exception: up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction

Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy (patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy), epigenetic therapy, etc.

Cannot have received: targeted therapy

Exception: up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction

Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy (patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy), epigenetic therapy, etc.

Cannot have received: radiation therapy

Exception: patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy

Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy (patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy), epigenetic therapy, etc.

Cannot have received: epigenetic therapy

Exception: up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction

Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy (patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy), epigenetic therapy, etc.

Lab requirements

Blood counts

ANC ≥ 1.0 × 10^9/L; Platelet ≥ 50 × 10^9/L; Hemoglobin ≥ 7.5 g/dL

Kidney function

Endogenous creatinine clearance ≥ 40 mL/min

Liver function

ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN

Cardiac function

No uncontrolled congestive heart failure (NYHA III/IV), myocardial infarction, CABG or unstable angina within 6 months prior to apheresis, no history of clinically significant uncontrolled cardiac arrhythmias, severe non-ischemic cardiomyopathy, LVEF < 50%, or other significant heart disease

Hematology: Absolute neutrophil (ANC) count ≥ 1.0 × 10^9/L; Platelet (PLT) ≥ 50 × 10^9/L; Hemoglobin (Hb) ≥ 7.5 g/dL; Blood chemistry: Endogenous creatinine clearance ≥ 40 mL/min; ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; Cardiac: see exclusion criteria 11

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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