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MC-1-50

Phase 1

Acute Lymphoblastic Leukemia, in Relapse | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Dec 22, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

MC-1-50 · 3 trials · 6 indications

Phase 1 3
NCT06892145Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLESystemic Lupus Erythematosus (SLE)
RECRUITING12 Analytics
NCT06641024Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALLAcute Lymphoblastic Leukemia, in Relapse
NOT YET_RECRUITING24 Analytics
NCT06180174Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell LymphomaB Cell Lymphoma
RECRUITING24 Analytics
PHASE1RECRUITING
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
Systemic Lupus Erythematosus (SLE)Unlock trial analytics
PHASE1NOT YET_RECRUITING
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL
Acute Lymphoblastic Leukemia, in RelapseUnlock trial analytics
PHASE1RECRUITING
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
B Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
1 month

Dose-limiting toxicity after CD19 CAR-T cell infusion

Secondary Endpoints

Validity endpoint of MC-1-50 cells [Efficacy]
3 months
AUCS of MC-1-50 cells [Cell dynamics]
3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
3 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MC-1-50EXPERIMENTALPatients will be be treated with CD19 CAR- T cells
MC-1-50 cell preparationEXPERIMENTALPatients will be be treated with CD19 CAR- T cells

Interventions

NameTypeDescription
MC-1-50BIOLOGICALA single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study; 2. Age ≥ 18 years old , gender not limited; 3. Patient...

Countries:China
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Frequently asked questions about MC-1-50

What is MC-1-50 used for?

MC-1-50 is an investigational CD19-targeted CAR-T cell therapy being studied for B Cell Lymphoma, relapsed Acute Lymphoblastic Leukemia, and refractory Systemic Lupus Erythematosus (SLE). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does MC-1-50 target?

MC-1-50 targets CD19, a protein found on B cells. By directing CAR-T cells to CD19, the therapy is designed to eliminate malignant or autoreactive B cells involved in the diseases under study. This mechanism is being evaluated across oncology and autoimmune indications.

Who is developing MC-1-50?

MC-1-50 is being developed by Precision BioSciences, Inc., a company publicly traded under the ticker DTIL. The therapy is currently in Phase 1 clinical trials, with studies conducted at sites in China.

What phase is MC-1-50 in?

MC-1-50 is in Phase 1 clinical development. All three of its listed trials are Phase 1 studies, and the drug remains investigational. It has not received FDA approval or any other regulatory approval for commercial use.

What clinical trials is MC-1-50 in?

MC-1-50 is being studied in three Phase 1 trials: NCT06180174 for relapsed/refractory B Cell Lymphoma, NCT06641024 for relapsed/refractory B-ALL, and NCT06892145 for refractory SLE. The lymphoma and SLE trials are recruiting, while the B-ALL trial is not yet recruiting.

Is MC-1-50 the same as a CD19 CAR-T cell therapy?

MC-1-50 is a CD19-targeted CAR-T cell therapy. Its clinical trials are titled as studies of CD19-targeted CAR-T cells, indicating that MC-1-50 is a form of this cell therapy approach. It is being evaluated in both blood cancers and autoimmune disease.