Last reviewed 2026-05-28 · How we verify

TriCAR-T-CD19

Timmune Biotech Inc. · Phase 1 active Biologic ✓ Verified May 2026

TriCAR-T-CD19 is a Biologic drug developed by Timmune Biotech Inc.. It is currently in Phase 1 development.

TriCAR-T-CD19 is a cell therapy used to treat children with CD19+ Leukemia and Non-Hodgkin Lymphoma, typically in combination with lymphodepletion chemotherapy. It is a form of adoptive immunotherapy that involves the use of autologous T-cells engineered to target CD19.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	TriCAR-T-CD19
Sponsor	Timmune Biotech Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL) (PHASE1)
Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy (EARLY_PHASE1)
Treatment of Hematological Malignancy With Novel CAR-T Cells. (EARLY_PHASE1)
Treatment of Refractory/Relapsed Non-Hodgkin Lymphoma With CD19-TriCART Cell Therapy (PHASE1)
Treatment of Refractory/Relapsed Non-Hodgkin Lymphoma With TriCAR-T_CD19 (PHASE1, PHASE2)
Treatment of Children CD19+ Leukemia and Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy (EARLY_PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

TriCAR-T-CD19 CI brief — competitive landscape report
TriCAR-T-CD19 updates RSS · CI watch RSS
Timmune Biotech Inc. portfolio CI

Frequently asked questions about TriCAR-T-CD19

What is TriCAR-T-CD19?

TriCAR-T-CD19 is a Biologic drug developed by Timmune Biotech Inc..

Who makes TriCAR-T-CD19?

TriCAR-T-CD19 is developed by Timmune Biotech Inc. (see full Timmune Biotech Inc. pipeline at /company/timmune-biotech-inc).

What development phase is TriCAR-T-CD19 in?

TriCAR-T-CD19 is in Phase 1.

Manufacturer: Timmune Biotech Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing