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DRUG:

PIT565

i
Other names: PIT565, PIT-565, PIT 565
Associations
Trials
Company:
Novartis
Drug class:
CD3 agonist, CD19 inhibitor, CD2 agonist
Related drugs:
Associations
Trials
8d
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). (clinicaltrials.gov)
P1, N=54, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Nov 2027 --> Jul 2027 | Trial primary completion date: Nov 2027 --> Jul 2027
Enrollment open • Trial completion date • Trial primary completion date
|
PIT565
5ms
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). (clinicaltrials.gov)
P1, N=54, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2028 --> Nov 2027 | Trial primary completion date: Jul 2028 --> Nov 2027
Trial completion date • Trial primary completion date
|
PIT565
8ms
New P1 trial
|
PIT565
12ms
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (clinicaltrials.gov)
P1, N=140, Recruiting, Novartis Pharmaceuticals | Trial completion date: Feb 2026 --> Jun 2028 | Trial primary completion date: Feb 2025 --> Jun 2027
Trial completion date • Trial primary completion date
|
CD19 positive
|
PIT565
1year
A Phase 1 Study of PIT565, a First-in-Class, Anti-CD3, Anti-CD19, Anti-CD2 Trispecific Antibody in Patients with Relapsed and/or Refractory B-Cell Malignancies (ASH 2023)
Patients with contraindication to tocilizumab; history of other malignant disease; active central nervous system involvement; autoimmune disease (other than patients with vitiligo, hypothyroidism only requiring hormone replacement, or psoriasis not requiring systemic treatment or conditions not expected to recur); or receiving systemic treatment with any immunosuppressive medication are not eligible. The dose escalation phase is guided by an adaptive Bayesian logistic regression model following the escalation with overdose control principle. The MTD and/or RD are further explored during the dose-expansion phase.
Clinical • P1 data • Trispecific
|
CD8 (cluster of differentiation 8) • CD58 (CD58 Molecule)
|
CD19 positive
|
Actemra IV (tocilizumab) • PIT565
over1year
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (clinicaltrials.gov)
P1, N=140, Recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2025 --> Feb 2026 | Trial primary completion date: Aug 2024 --> Feb 2025
Trial completion date • Trial primary completion date
|
CD19 positive
|
PIT565
2years
PIT565, a First-in-Class Anti-CD19, Anti-CD3, Anti-CD2 Trispecific Antibody for the Treatment of B Cell Malignancies (ASH 2022)
The robust expression of the CD19 antigen in ALL and NHL has resulted in the development of highly effective therapeutics targeting CD19 by leveraging redirected T cells, which include the bispecific T-cell engager blinatumomab and CD19-directed CAR-T therapies axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. Taken together, the findings from the preclinical studies suggest that PIT565 may achieve deeper and more durable responses compared to competitor CD3 bispecifics. First-in-human trial of PIT565 (NCT05397496) has been initiated and will be conducted in patients who are diagnosed with relapsed and/or refractory adult NHL after receiving two or more lines of chemotherapy and patients with relapsed and/or refractory B-ALL.
IO biomarker
|
CD58 (CD58 Molecule)
|
CD19 positive • CD19 expression
|
Blincyto (blinatumomab) • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • PIT565
2years
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (clinicaltrials.gov)
P1, N=140, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
Enrollment open
|
CD19 (CD19 Molecule)
|
CD19 positive
|
PIT565
over2years
New P1 trial
|
CD19 (CD19 Molecule)
|
CD19 positive
|
PIT565